FDA OKs Merck’s Antiviral Covid Drug
The vote was 13 for and 10 against, so the first-of-its-kind drug was narrowly approved. Merck also said it should be effective against the new omicron variant. Meanwhile, Regeneron's antibody treatment may not be, according to the company.
NPR:
An FDA Panel Supports Merck COVID Drug in Mixed Vote
A panel of experts advising the Food and Drug Administration voted narrowly in favor of emergency use authorization of an antiviral pill from Merck and Ridgeback Biotherapeutics to treat COVID-19. The vote was 13 for and 10 against authorization. The FDA isn't obligated to follow the recommendations of its advisers but typically does. (Hensley, 11/30)
AP:
US Panel Backs First-Of-A-Kind COVID-19 Pill From Merck
“I see this as an incredibly difficult decision with many more questions than answers,” said panel chair Dr. Lindsey Baden of Harvard Medical School, who voted in favor of the drug. He said FDA would have to carefully tailor the drug’s use for patients who stand to benefit most. The recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Most experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, such as pregnancy tests for women of child-bearing age. (Perrone, 12/1)
On effectiveness against omicron —
Reuters:
Merck Says Its COVID-19 Drug Should Be Effective Against Any Variant
Merck & Co Inc's experimental COVID-19 drug molnupiravir should have similar activity against any new coronavirus variant, a company executive said on Tuesday. The drug, developed along with Ridgeback Biotherapeutics, shows antiviral properties against coronavirus variants such as the Delta variant, Daria Hazuda, vice president of Merck's infectious diseases and vaccines division, said. (11/30)
Meanwhile, in news on antibody drugs —
The New York Times:
Regeneron Antibody Treatment May Not Be As Effective Against New Omicron Covid Variant
Regeneron said on Tuesday that its Covid-19 antibody treatment might be less effective against the Omicron variant of the coronavirus, an indication that the popular and widely beneficial monoclonal antibody drugs may need to be updated in case the new variant spreads aggressively. The company said that previous laboratory analyses and computer modeling of certain mutations in the Omicron variant suggest that they may weaken the effect of the treatment. But studies using the variant’s full sequences have not been completed, it said. (Mueller, 11/30)
AP:
Massachusetts Deploying COVID-19 Antibody Treatment Units
Massachusetts is deploying three mobile units to administer monoclonal antibody treatment to high-risk individuals who have been exposed to or have COVID-19, Gov. Charlie Baker said Tuesday. The clinics have the capacity to treat up to 500 patients per week with therapies that have can help reduce the severity of the disease and keep COVID-19-positive individuals from being hospitalized. (11/30)
