WASHINGTON (BLOOMBERG) – The US Food and Drug Administration will send Merck’s Covid-19 pill to an advisory committee for review, using a public forum to discuss any safety concerns ahead of a potential authorisation, according to a person familiar with the plans.
The FDA announcement is expected imminently, and means the agency opted not to skip the advisory committee step, which it occasionally does when it’s racing to get a drug to market quickly.
Safety concerns have been raised by some experts, and the committee will weigh in before the FDA makes a decision, the person said.
Merck and its partner Ridgeback Biotherapeutics sought emergency use authorisation in the US for molnupiravir earlier this week, a step toward clearance for a pill meant to treat Covid-19 in high-risk adults.
Kenilworth, New Jersey-based Merck agreed in June to a US$1.2 billion supply deal to provide the US government 1.7 million courses of treatment once the drug gains FDA authorisation or approval.
Molnupiravir works by introducing errors into viral genetic material that eventually make the pathogen defunct.
Some experts have questioned whether and how the drug may also impact growing cells in the human body, potentially raising the risk of birth defects, for example.
Nicholas Kartsonis, senior vice president of clinical research for infectious diseases and vaccines at Merck Research Labs, said in an interview last week that he’s been “very impressed” by the drug’s safety profile and that it looks “really clean.”
In trials, more people stopped taking the placebo due to serious adverse events than the drug itself, he said.
Join ST’s Telegram channel here and get the latest breaking news delivered to you.
Source: Read Full Article