FDA Panel Narrowly Approves Merck COVID-19 Pill

November 30, 2021 by Dan McCue
FDA Panel Narrowly Approves Merck COVID-19 Pill
This undated file image provided by Merck & Co. shows their new antiviral medication molnupiravir. An experimental COVID-19 drug that could soon become the first U.S.-authorized pill to treat the coronavirus faces one final hurdle Tuesday: A panel of government experts will scrutinize data on the medication from drugmaker Merck. (Merck & Co. via AP, File)

WASHINGTON — An advisory panel for the Food and Drug Administration narrowly approved the use of a COVID-19 pill manufactured by Merck.

If the agency accepts the recommendation, molnupiravir would be the first drug Americans could be prescribed and take at home to treat the virus.

The 13-10 vote by the panel came after an extended debate over the drug’s benefits and safety issues, such as the risk of birth defects if used during pregnancy.

In the end, the advisory panel said the drug should definitely not be used by pregnant women and should be labelled with extra safety precautions.

The panel backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including those with conditions like obesity, asthma and old age.

The pill is already authorized in the United Kingdom. Last week, Merck said final study results showed molnupiravir reduced hospitalization and death by 30% among adults infected with the coronavirus, when compared with adults taking a placebo. 

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue

A+
a-
TWN
  • COVID-19
  • FDA
  • Merck
    • linkedin linkedin

    In The News

    Health

    Voting

    Prescription Drugs

    November 28, 2023
    by Dan McCue
    FDA Approves First Therapy for Rare Type of Non-Cancerous Tumors

    WASHINGTON — The Food and Drug Administration on Tuesday approved Ogsiveo tablets for adult patients with progressing desmoid tumors, a... Read More

    WASHINGTON — The Food and Drug Administration on Tuesday approved Ogsiveo tablets for adult patients with progressing desmoid tumors, a rare subtype of soft tissue sarcomas. Desmoid tumors are non-cancerous but can be locally aggressive, invading surrounding structures and organs, causing pain and disability. Although surgical... Read More

    November 13, 2023
    by Obesity Drug Wegovy Cut Risk of Serious Heart Problems by 20%, Study Finds
    Obesity Drug Wegovy Cut Risk of Serious Heart Problems by 20%, Study Finds

    The popular weight-loss drug Wegovy reduced the risk of serious heart problems by 20% in a large, international study that... Read More

    The popular weight-loss drug Wegovy reduced the risk of serious heart problems by 20% in a large, international study that experts say could change the way doctors treat certain heart patients. The research is the first to document that an obesity medication can not only pare... Read More

    November 7, 2023
    by Mind-Altering Ketamine Becomes Latest Pain Treatment, Despite Little Research
    Mind-Altering Ketamine Becomes Latest Pain Treatment, Despite Little Research

    WASHINGTON (AP) — As U.S. doctors scale back their use of opioid painkillers, a new option for hard-to-treat pain is taking... Read More

    WASHINGTON (AP) — As U.S. doctors scale back their use of opioid painkillers, a new option for hard-to-treat pain is taking root: ketamine, the decades-old surgical drug that is now a trendy psychedelic therapy. Prescriptions for ketamine have soared in recent years, driven by for-profit clinics and telehealth... Read More

    November 1, 2023
    by Dan McCue
    FDA Approves Biosimilar for Treatment of Multiple Inflammatory Diseases

    WASHINGTON — The Food and Drug Administration on Tuesday approved Wezlana, a biosimilar interchangeable with Stelara for the treatment of... Read More

    WASHINGTON — The Food and Drug Administration on Tuesday approved Wezlana, a biosimilar interchangeable with Stelara for the treatment of multiple inflammatory diseases. The agency said its approval of Wezlana, which is manufactured by Amgen, was based on a comprehensive review of scientific evidence demonstrating that... Read More

    October 18, 2023
    by STUDY: Drug Used in Diabetes Treatment Mounjaro Helped Dieters Shed 60 Pounds
    STUDY: Drug Used in Diabetes Treatment Mounjaro Helped Dieters Shed 60 Pounds

    The medicine in the diabetes drug Mounjaro helped people with obesity or who are overweight lose at least a quarter... Read More

    The medicine in the diabetes drug Mounjaro helped people with obesity or who are overweight lose at least a quarter of their body weight, or about 60 pounds on average, when combined with intensive diet and exercise, a new study shows. By comparison, a group of... Read More

    October 16, 2023
    by Rite Aid Seeks Chapter 11 Bankruptcy Protection as It Deals With Lawsuits and Losses
    Rite Aid Seeks Chapter 11 Bankruptcy Protection as It Deals With Lawsuits and Losses

    Rite Aid has filed for bankruptcy protection and plans to sell part of its business as it attempts to restructure... Read More

    Rite Aid has filed for bankruptcy protection and plans to sell part of its business as it attempts to restructure while dealing with losses and opioid-related lawsuits. The drugstore chain said late Sunday it also has obtained $3.45 billion in fresh financing from some of its... Read More

    News From The Well
    scroll top