Eli Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern

By Carl O’Donnell and Michael Erman



a large building: FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego


© Reuters/MIKE BLAKE
FILE PHOTO: Eli Lilly logo is shown on one of their offices in San Diego

(Reuters) – Eli Lilly & Co on Wednesday said other trials of its experimental coronavirus antibody therapy remain on track after a government-run study testing the treatment in hospitalized COVID-19 patients was paused due to safety concerns.

Lilly said on Tuesday that an independent safety monitoring board requested a pause in the trial, called ACTIV-3, due to a potential safety issue.

The National Institutes of Health (NIH), which is collaborating with Lilly on the trial, said the advisory board paused the trial after seeing a “difference in clinical status” between patients on Lilly’s drug on those who received a placebo, without providing further detail.

Lilly on Wednesday said the paused trial is distinct from others it is conducting because it focuses on hospitalized patients who are more severely ill and being treated with other drugs as well, including Gilead Sciences Inc’s antiviral remdesivir.

The company had already asked U.S. regulators for an emergency use authorization (EUA) for the antibody drug, called bamlanivimab or LY-CoV555, to treat mild to moderate COVID-19 patients, based on interim data from a different study in those less severe illness. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration did not immediately respond to a request for comment on the status of the EUA application.

LY-CoV555 is similar to the experimental dual-antibody therapy from Regeneron Pharmaceuticals Inc that was used to treat U.S. President Donald Trump. That treatment is also awaiting clearance by U.S. regulators.

Trump touted both drugs as being tantamount to cures in a video he posted last week after being released from the hospital.

Lilly said in a statement that these type of treatments may prove to be less beneficial for hospitalized patients than for those with more mild cases of the disease. A Lilly spokeswoman declined to comment further on why the trial was halted.

The paused trial is being conducted in partnership with the U.S. National Institute of Allergy and Infectious Diseases, a division of the NIH that is working with several drugmakers on COVID-19 treatments and vaccines.

It was halted at the request of an independent oversight panel, called a Data Safety and Monitoring Board (DSMB). It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem.

“Lilly trusts the judgment of the independent DSMB and supports its decisions to exercise caution in ensuring the safety of the patients participating in this study,” the company said in a statement.

(Reporting by Carl O’Donnell; Editing by Chizu Nomiyama and Bill Berkrot)

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Taysha Gene Therapies Receives Rare Pediatric Disease Designation and Orphan Drug Designation for TSHA-102 as a Treatment for Rett Syndrome

Program leverages novel miRARE platform technology used to control transgene expression on a cellular basis

TSHA-102 anticipated to submit Investigational New Drug application in 2021

Taysha Gene Therapies Inc. (Nasdaq: TSHA), a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations, today announced that it has received rare pediatric disease designation and orphan drug designation from the U.S. Food and Drug Administration (FDA) for TSHA-102, an AAV9-based gene therapy in development for the treatment of Rett syndrome. Taysha anticipates that it will submit an Investigational New Drug (IND) application for TSHA-102 to the FDA in 2021.

Rett syndrome is one of the most common genetic causes of severe intellectual disability worldwide, with a prevalence of over 25,000 cases in the U.S. and European Union (EU). It is an X-linked disease that primarily occurs in females, but it can be seen very rarely in males. It is usually recognized in children between six to 18 months of age as they begin to miss developmental milestones or lose abilities they had developed. Individuals with Rett syndrome also show symptoms that include loss of speech, loss of purposeful use of hands, loss of mobility, seizures, cardiac impairments, breathing issues and sleep disturbances.

“Patients with Rett syndrome are currently managed with symptomatic treatments as there are no therapies approved to treat the underlying cause of disease,” said Berge Minassian, M.D., Chief Medical Advisor of Taysha and Chief of Pediatric Neurology at the University of Texas Southwestern Medical Center (UT Southwestern). Dr. Minassian is credited with describing the CNS isoform of the MECP2 gene which is responsible for neuronal and synaptic function throughout the brain. “Gene therapy offers a potentially curative option for patients suffering with Rett syndrome.”

Rett syndrome is caused by mutations in the MECP2 gene. TSHA-102 is designed to deliver a healthy version of the MECP2 gene as well as the miRNA-Responsive Auto-Regulatory Element, miRARE, platform technology to control the level of MECP2 expression. “TSHA-102 represents an important step forward in the field of gene therapy, where we are leveraging a novel regulatory platform called miRARE to prevent the overexpression of MECP2,” said Steven Gray, Ph.D., Chief Scientific Advisor of Taysha and Associate Professor in the Department of Pediatrics at UT Southwestern. “In collaboration with Sarah Sinnett, Ph.D. to develop miRARE, our goal was to design a regulated construct that allowed us to control MECP2 expression to potentially avoid adverse events that are typically seen with unregulated gene therapies.”

The FDA defines a rare pediatric disease as a serious or life-threatening disease in which the disease manifestations primarily affect individuals aged from birth to 18 years. Pediatric diseases recognized as “rare” affect under 200,000 people in the U.S. The Rare Pediatric Disease Priority Review Voucher Program is intended to address the challenges that drug companies face when developing treatments for these unique patient populations. Under this program, companies are

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First Databank Selected as Drug Database Provider for CliniComp, Intl.’s Full-Service EHR Pharmacy Solution

Healthcare industry’s most trusted drug database to drive streamlined inpatient pharmacy workflows for hospitals using CliniComp’s EHR

First Databank, Inc. (FDB), the leading provider of drug and medical device knowledge that helps healthcare professionals make precise decisions, has been selected to supply the drug database for a new and expanded EHR pharmacy module to be offered by CliniComp, Intl., a global provider of hospital-wide clinical documentation systems and electronic health record (EHR) solutions.

CliniComp will integrate the FDB MedKnowledge® database into its EHR to drive a single, full-service pharmacy and medication management system designed to simplify all inpatient pharmacy workflows, including computerized physician order enter (CPOE), medication dispensing and administration.

“Hospitals today need a more robust integrated pharmacy workflow management system within the EHR to make ordering, conflict checking, documenting and dispensing medications easier and more accurate,” said Nancy Pratt, RN, MSN, Senior Vice President Clinical Product Design of CliniComp, Intl. “FDB MedKnowledge will support CliniComp to deliver a more intuitive, easy-to-use solution across all medication workflows, while facilitating meaningful clinical decision support [CDS] alerts, seamless interoperability and smarter data analytics.”

Pratt explained: “We also chose MedKnowledge because the database features excellent organization and structure. This will enable CliniComp to furnish clinicians with access to the right medication information appropriate for their contexts, as well as detailed drug product classifications for more precise selection of drugs.”

Bob Katter, President of FDB, said the alliance will streamline pharmacy workflows to make ordering and dispensing medications more efficient for clinicians. “We will provide CliniComp’s users with meaningful, targeted and actionable medication guidance to support their clinical decision-making,” Katter said. “This will help further improve patient care and safety.”

The new CliniComp pharmacy system powered by FDB MedKnowledge will:

  • Save clinicians time with faster order processing via intelligent dispensing. The system will automate package choice and medication ordering based on criteria such as patient-specific parameters and medication inventory.

  • Save hospitals implementation time via the use of prebuilt medication concepts offered within MedKnowledge. The new full function pharmacy system will provide a foundation from which hospitals can more quickly tailor a solution to meet specific needs.

  • Save hospitals time and resources in updating medication information while ensuring the latest drug data is readily available to clinicians. MedKnowledge will facilitate automated medication updates with minimal post-load maintenance, so there is no downtime.

In addition to FDB MedKnowledge, CliniComp plans to implement the FDB Interoperability Module™ to enhance medication reconciliation and interoperability with external hospital systems, such as automated dispensing cabinets.

About First Databank (FDB)

First Databank (FDB) is the leading provider of drug and medical device knowledge that helps healthcare professionals make precise decisions. We empower our information system developer partners to deliver valuable, useful, and differentiated solutions used by millions of clinicians, business associates, and patients every day. For more than four decades, our medical knowledge has helped improve patient safety, operational efficiency, and healthcare outcomes. For a complete look at our solutions and services, please visit www.fdbhealth.com and follow us on

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Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that vaccine resumed in other regions after a brief halt.

Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.

It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Because of the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide – and the speed with which they are being developed – these trials have come under intense scrutiny.

“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The Indianapolis-based drugmaker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration and the National Institutes of Health did not immediately reply to requests for comment.

Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States.

The trial compares patients who receive its antibody drug plus Gilead Sciences Inc’s antiviral drug remdesivir with those who receive remdesivir alone.

Lilly sought the EUA from U.S. regulators after publishing data in September showing LY-CoV555 helped cut hospitalization and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.

Lilly shares closed nearly 3%.

(Reporting by Michael Erman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot)

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Drug Interaction Checker – Find Interactions Between Medications

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DISCLAIMER: The information contained herein should NOT be used as a substitute for the advice of an appropriately qualified and licensed physician or other health care provider. The information provided here is for informational purposes only. This tool may not cover all possible drug interactions. Please check with a physician if you have health questions or concerns. Although we attempt to provide accurate and up-to-date information, no guarantee is made to that effect.

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Amlodipine: Drug Uses, Side Effects & Dosage

Generic Name: amlodipine (am LOE di peen)
Brand Names: Katerzia, Norvasc

Medically reviewed by Sanjai Sinha, MD Last updated on Dec 1, 2019.

What is amlodipine?

Amlodipine is a calcium channel blocker that dilates (widens) blood vessels and improves blood flow.

Amlodipine is used to treat chest pain (angina) and other conditions caused by coronary artery disease.

Amlodipine is also used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Amlodipine is for use in adults and children who are at least 6 years old.

Important information

Before taking amlodipine, tell your doctor if you have congestive heart failure or liver disease.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of amlodipine.

If you are being treated for high blood pressure, keep using amlodipine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Amlodipine is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Tell your doctor about all other heart or blood pressure medications you are taking.

Your chest pain may become worse when you first start taking amlodipine or when your dose is increased. Call your doctor if your chest pain is severe or ongoing.

Before taking this medicine

You should not take amlodipine if you are allergic to it.

To make sure amlodipine is safe for you, tell your doctor if you have ever had:

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether amlodipine will harm an unborn baby. However, having high blood pressure during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating hypertension may outweigh any risks to the baby.

Amlodipine can pass into breast milk, but effects on the nursing baby are not known. Tell your doctor if you are breast-feeding.

Amlodipine is not approved for use by anyone younger than 6 years old.

How should I take amlodipine?

Take amlodipine exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take amlodipine with or without food. Take the medicine at the same time each day.

Shake the Katerzia oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Your blood pressure will need to be checked often.

Your chest pain may become worse when you first start taking amlodipine or when your dose is increased. Call your doctor if your chest pain is severe or

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RxList Drug Medical Dictionary with Medical Definitions

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Need help identifying pills? Try the RxList Pill Identifier Tool.


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DrugFacts: Marijuana as Medicine | National Institute on Drug Abuse (NIDA)

What is medical marijuana?

The term medical marijuana refers to using the whole, unprocessed marijuana plant or its basic extracts to treat symptoms of illness and other conditions. The U.S. Food and Drug Administration (FDA) has not recognized or approved the marijuana plant as medicine.

However, scientific study of the chemicals in marijuana, called cannabinoids, has led to two FDA-approved medications that contain cannabinoid chemicals in pill form. Continued research may lead to more medications.

Because the marijuana plant contains chemicals that may help treat a range of illnesses and symptoms, many people argue that it should be legal for medical purposes. In fact, a growing number of states have legalized marijuana for medical use.

Why isn’t the marijuana plant an FDA-approved medicine?

The FDA requires carefully conducted studies (clinical trials) in hundreds to thousands of human subjects to determine the benefits and risks of a possible medication. So far, researchers haven’t conducted enough large-scale clinical trials that show that the benefits of the marijuana plant (as opposed to its cannabinoid ingredients) outweigh its risks in patients it’s meant to treat.

Read more about the various physical, mental, and behavioral effects of marijuana in our Marijuana DrugFacts.

Medical Marijuana Laws and Prescription Opioid Use Outcomes

A new study underscores the need for additional research on the effect of medical marijuana laws on opioid overdose deaths and cautions against drawing a causal connection between the two. Early research suggested that there may be a relationship between the availability of medical marijuana and opioid analgesic overdose mortality. In particular, a NIDA-funded study published in 2014 found that from 1999 to 2010, states with medical cannabis laws experienced slower rates of increase in opioid analgesic overdose death rates compared to states without such laws.1 

A 2019 analysis, also funded by NIDA, re-examined this relationship using data through 2017. Similar to the findings reported previously, this research team found that opioid overdose mortality rates between 1999-2010 in states allowing medical marijuana use were 21% lower than expected. When the analysis was extended through 2017, however, they found that the trend reversed, such that states with medical cannabis laws experienced an overdose death rate 22.7% higher than expected.2 The investigators uncovered no evidence that either broader cannabis laws (those allowing recreational use) or more restrictive laws (those only permitting the use of marijuana with low tetrahydrocannabinol concentrations) were associated with changes in opioid overdose mortality rates.

These data, therefore, do not support the interpretation that access to cannabis reduces opioid overdose. Indeed, the authors note that neither study provides evidence of a causal relationship between marijuana access and opioid overdose deaths. Rather, they suggest that the associations are likely due to factors the researchers did not measure, and they caution against drawing conclusions on an individual level from ecological (population-level) data. Research is still needed on the potential medical benefits of cannabis or cannabinoids.

Read more in our Marijuana Research Report.

What are cannabinoids?

Cannabinoids are chemicals related to delta-9-tetrahydrocannabinol

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Z Drug List from Drugs.com

The resources below have been provided to help narrow your search to specific, targeted drug information. Information is available for both consumers and healthcare professionals on over 24,000 prescription and over the counter medicines available primarily in the USA.

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Cerner Multum

Cerner Multum Consumer Drug Information

Multum leaflets provide basic consumer drug information, such as drug descriptions and interactions, details of possible side effects and the effects of missed doses and overdosing, as well as instructions for use. The leaflets are available in English and Spanish.

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MedFacts Consumer Drug Information

Sourced from leading health information provider Wolters Kluwer Health, Facts & Comparisons Integrated MedFacts consumer drug information leaflets provide detailed information on drug indications, contraindications and interactions as well as notes on safety and instructions for use. Facts and Comparisons has been a key source of drug information for pharmacists for more than fifty years. Also known as Medispan IMM.

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IBM Watson Micromedex Consumer Information (Advanced)

IBM Watson Micromedex Advanced Consumer Information provides comprehensive consumer information pertaining to a wide variety of drugs, such as a list of commonly used brand names, drug descriptions, warnings and precautions, and detailed information on the proper use of each drug.

Professional Drug Sources

American Society of Health-System Pharmacists

AHFS DI Monographs

AHFS DI from the American Society of Health-System Pharmacists’ (ASHP) is the most comprehensive source of unbiased and authoritative drug information available to health professionals today. A wholly independent staff of drug information pharmacists and other professional editorial and analytical staff thoroughly research AHFS DI content. Authors incorporate clinical research findings, therapeutic guidelines, and Food and Drug Administration (FDA) approved labeling to ensure that monographs include an evidence-based foundation for safe and effective drug therapy.

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A-Z Drug Facts (Facts & Comparisons)

Drugs.com provides A-Z Drug Facts for the professional. Wolters Kluwer Health is a leading provider of information for professionals and students in medicine, nursing, allied health, pharmacy and the pharmaceutical industry. Wolters Kluwer Health drug information product, Facts & Comparisons, has been the pharmacists’ source for drug information for more than fifty years.

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FDA Professional Drug Information

The Professional Drug Information database is a repository of drug information sourced directly from the FDA. It includes detailed notes on the clinical pharmacology of a wide variety of drugs.

Natural Product Sources

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The MedFacts Natural Products Consumer database is a comprehensive source of information on traditional and/or conventional uses of natural products. A basic overview of each product is provided (including dosages, possible drug interactions, side effects and contraindications) along with safety and/or efficacy ratings from Wolters Kluwer Health.

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MedFacts Natural Products Information (Professional)

The MedFacts Natural Products Professional database is a comprehensive source of information on traditional and/or conventional uses of natural products. A basic overview of each product is provided (including dosages, possible drug interactions, side effects and contraindications) along with safety and/or efficacy ratings from Wolters Kluwer Health.

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Prescription Drug Information, Interactions & Side Effects

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