FDA unlikely to authorize Merck’s COVID pill before December [Video]

WHAT YOU NEED TO KNOW:

• The FDA will hold a meeting on November 30 with its outside experts to scrutinize Merck’s anti-Covid-19 pill.
• The meeting means the FDA is not likely to issue any authorization for Merck’s experimental drug, molnupiravir, until December.
• If authorized, molnupiravir would be the first at-home treatment that patients can use to ease symptoms and hasten recovery.

The US Food and Drug Administration said Thursday it will hold a meeting with its outside experts in late November to examine Merck’s anti-Covid-19 pill.

The meeting, which is set for November 30, means the FDA is not likely to issue any authorization for the drug until December. The US regulators will conduct a detailed review of Merck’s experimental drug in terms of safety and effectiveness.

The panelists will then vote on whether the drug should be approved, though the FDA is not required to follow their advice.

It marks the first time the FDA has convened its expert advisers before ruling on a coronavirus treatment. Advisory committee meetings have become a standard part of its process for reviewing vaccines.

The FDA decided to convene the meeting to help inform its decision-making, its top drug regulator said in a statement.

“We believe that, in this instance, a public discussion of these data with the agency’s advisory committee will help ensure clear understanding of the scientific data and information that the FDA is evaluating,” said Dr. Patrizia Cavazzoni, director of FDA’s drug center.

The FDA said the meeting was scheduled as soon as possible following Merck’s request. The November date will allow agency scientists to review the application ahead of the meeting.

Merck and its partner Ridgeback Biotherapeutic filed their FDA application on Monday, asking the agency to grant emergency use for adults with mild to moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the same indication as available infusion drugs.

Three IV antibody drugs have been authorized since last year to cut COVID-19 hospitalization and death, but they are expensive, hard to produce and require specialty equipment and health professionals to deliver. If authorized, Merck’s drug, molnupiravir, would be the first that patients could take at home to ease symptoms and speed recovery.

The company announced preliminary results earlier this month showing its drug cut hospitalizations and deaths by half among patients with early COVID-19 symptoms. The results have not yet been peer-reviewed, the standard practice for vetting such research.

Merck also has not disclosed details on molnupiravir’s side effects, except to say that rates of those problems were similar between people who got the drug and those who received dummy pills.

If authorized, Merck’s drug is likely to be the first — but not the only — pill to treat COVID-19. Pfizer, Roche and Appili Therapeutics are each studying similar drugs and are expected to report results in the coming weeks and months.

Source: ABC News