The FDA may finally approve molnupiravir in us

The FDA may finally approve molnupiravir in us

It is likely that Merck's COVID 19 pill will be authorized in the U.S. this month, even though Wall Street cooled and physicians raised questions about the drug's efficacy and safety profile, particularly among people who are pregnant.

The shares of Merck Co. Inc. MRK went up by 1.6% in trading on Wednesday after an advisory panel recommended that the Food and Drug Administration approve molnupiravir in a narrow 13 -- 10 vote.

The near split vote reflects concerns over molnupiravir's modest clinical efficacy, with results in the post-interim period contrasting with the more positive interim results that led to early study stoppage, SVB Leerink analysts told investors on Wednesday. We expect these concerns to follow the therapy and limit uptake when alternative therapies become available. The company, which is developing molnupiravir with the privately held Ridgeback Biotherapeutics, is seeking authorization in adults who have tested positive for the virus and are at high risk of hospitalization and death. Within five days of symptoms, treatment is expected to begin.

If authorized, it will be the first oral pill that can treat COVID - 19.

Analysts think that the FDA will restrict who can take the drug for safety reasons, possibly limiting the use of molnupiravir to people older than 60 years old, or excluding pregnant women, women of childbearing age, and male partners. Some FDA panelists suggested that women have to have a negative pregnancy test to get the pill.

Mizuho Securities analysts think the FDA will limit authorization to the nonpregnant adult population. Wall Street had a muted response to the panel vote and now to the drug in general.

Raymond James Steven Seedhouse described the approval as tepid and said it would be an uphill battle for full approval, given the availability of myriad neutralizing antibodies and likely Paxlovid another oral medication with seemingly lesser tox concerns soon. Merck shared interim data in October showing that molnupiravir can reduce the risk of hospitalization and death by 50%. The news exhilarated just about everyone. Markets soared, and physicians applauded the arrival of a promising new tool in the pandemic.

But then a couple of things happened: Pfizer shared interim data for its COVID 19 pill in November that showed Paxlovid reduced the risk of hospitalization and death by a remarkable 89%, and then Merck released full data on the day after Thanksgiving that showed the drug didn't work as well as we thought - it can reduce hospitalization and death by 30%, not 50%.

Merck's stock performance over the last two months reflects many of these ups and downs. The company's stock closed at $81.40 on October 1, the day it announced the interim data, marking the first time the stock closed higher than $81.00 since mid-January. But in November, the biggest monthly decline since dropping 15.2% in February 2009, fell 14.9%.

Merck's stock is down 3.9% this year, while the S&P 500 SPX is up 21.6%.