FDA advisers recommend Merck’s COVID-19 pill in close vote

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A Food and Drug Administration advisory committee said on Tuesday that Merck & Co.’s experimental antiviral COVID-19 pill’s benefits outweigh its risks in a 13-10 vote, with several advisers saying they should consider the drug’s use in pregnant women. I was worried.

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Merck MRK shares,
+0.03%
After ending the regular trading day by a fraction, it was up 2% in after-hours trading on Tuesday. The company is developing a pill called mollupiravir with privately held Ridgeback Biotherapeutics.

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The FDA is now expected to make its final decision before the end of this year. The regulator often takes into account the recommendations of its advisory committees but is not required to do so.

If molanupiravir is authorized by the FDA in the coming weeks, as expected, the treatment will be the first oral COVID-19 pill that patients can take at home.

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Members of the Antimicrobial Drug Advisory Committee also suggested a safety-monitoring program, expressed concerns about prescribing the drug for people who are immunized, and shared their concerns about the pill’s overall efficacy.

Some Wall Street analysts predicted that advisors would vote in support of the authority but with a cautious approach.

“Despite these reservations, Molnupiravir is also likely to be approved, and demand is likely to exceed their 20 [million] Supply of course in 2022,” SVB Leerink analysts wrote on Friday.

Most of the COVID-19 treatments currently available are used to care for very sick, hospitalized people. This includes the steroid dexamethasone and Gilead Sciences Inc. The Guild of
-2.43%
Vacklery.

Monoclonal antibody, developed by Eli Lilly & Co. LLY
-2.66%,
Regeneron Pharmaceuticals Inc. REGN,
-2.73%,
and Veer Biotechnology Inc. For,
+17.14%
and GlaxoSmithKline GSK,
-0.58%
Can be used to treat people with mild or moderate cases of COVID-19, but these treatments have to be administered by infusion in a clinical setting.

Molnupiravir was once touted as a game changer during the pandemic, but that has changed in importance as new data emerged from a clinical trial and a competitor stepped in.

Wall Street’s interest in the Merck pill began to wane in November when Pfizer Inc. pfe,
+2.54%
delivered even more compelling results for its COVID-19 drug candidate, demonstrating that Paxlovid reduced the risk of hospitalization and death by an astonishing 89% in clinical trials. The company filed for emergency authorization later in the month.

Then, last week, Merck shared that its pill reduced the risk of hospitalization and death in clinical trials by 30%—and not 50% as reported in interim results. Wall Street is now taking note of the growing concerns about the Omicron variant and the continued need for new and improved treatments for COVID-19.

Analysts at Mizuho Securities told investors on Monday, “Expectations are rising on the potential of Pfizer’s COVID-19 vaccine community regarding the new Omicron variant and updated data from Merck’s oral anti-viral mollupiravir to Pfizer’s anti-viral drug.” Raising hopes for Viral PaxLovid.”

Analysts were first over the moon about the sales potential of the oral COVID-19 pill, which predicts between $5 billion and $7 billion in sales next year alone. But the arrival of new efficacy data dampened interest in both the drug and Merck’s stock.

Citi on Monday downgraded Merck’s stock from buy to neutral, citing concerns about the company’s experimental HIV drugs islatravir and mollupirvir.

Merck is seeking authorization for molnupiravir in adults who have tested positive for the virus, are experiencing mild or moderate symptoms, and are at high risk for severe disease. Patients are expected to start treatment within 5 days of symptoms.

Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Study Only enrolled people who were not vaccinated; However, it is not clear whether the pill can be used to treat vaccinated individuals, if it is authorized.

Molnupiravir has already been authorized for use in the UK

Read more coverage about Merck and its COVID-19 pill:

Merck stock dives after Citi downgrades to ‘high probability’ HIV treatment will be abandoned

Merck’s COVID-19 pill could drive up to $7 billion in sales next year

Why the at-home pill could change the course of the pandemic

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