FDA advisors recommend Merck’s COVID-19 pill in secret ballot

The FDA is now expected to make its final decision, possibly before the end of the year. Regulators usually take into account the recommendations of their advisory committees but are not required to do so.

If molnupiravir is approved by the FDA in the coming weeks, the treatment is expected to be the first oral COVID-19 pill that patients can take at home.

Members of the Antibiotic Advisory Committee also proposed a safety surveillance program, expressed concerns about prescribing the drug to immunocompromised individuals, and shared their concerns about effectiveness. overall drug.

Some Wall Street analysts have predicted that advisers will vote in favor of the authorization but with a cautious approach.

“Despite these reservation requirements, molnupiravir is also likely to be approved and demand could exceed 20 [million] SVB Leerink analysts wrote on Friday.

Of the existing COVID-19 treatments, most are used to care for seriously ill, hospitalized people. This includes the steroid dexamethasone and that of Gilead Sciences Inc.
GILD,
-2.43%

Veklury.

The monoclonal antibodies developed by Eli Lilly & Co.
ONLY,
-2.66%,
Regeneron Pharmaceuticals Inc.
REGISTER,
-2.73%,
and Vir Biotechnology Inc.
VIR,
+ 17.14%

and GlaxoSmithKline
GSK,
-0.58%

can be used to treat people with mild or moderate COVID-19 disease, but these treatments must be administered by infusion in the clinical setting.

Molnupiravir was once seen as a game-changer during the course of the pandemic, but its importance changed as new data from the clinical trial was released and a competitor stepped up.

Wall Street’s interest in Merck’s pill began to wane in November when Pfizer Inc.
PFE,
+ 2.54%

produced more compelling results for the COVID-19 drug candidate, demonstrating that Paxlovid reduced the risk of hospitalization and death by an amazing 89% in a clinical trial. The company applied for an emergency authorization at the end of the month.

Then, last week, Merck shared that their pill reduced the risk of hospitalization and death by 30% in a clinical trial—and not 50% as reported in the interim results. Wall Street is now embracing growing worries about omicron variation and the continued need for new and better treatments for COVID-19.

“Concerns about the new omicron variant are raising expectations about the potential of Pfizer Comirnaty’s COVID-19 vaccine and updated data,” Mizuho Securities analysts told investors on Monday. from Merck’s antiviral molnupiravir is raising expectations for Pfizer’s antiviral Paxlovid.”

Analysts once revealed the sales potential of the first working oral COVID-19 pill, predicting between 5 billion dollars and 7 billion dollars in sales just next year. But the emergence of new efficacy data has dented interest in both the drug and Merck stock.

Citi on Monday Merck’s stock downgrade from neutral, from buy, citing concerns about the company’s testing HIV drug islatravir and about molnupiravir.

Merck is applying for permission to use molnupiravir in adults who test positive for the virus, have mild or moderate symptoms, and are at high risk for severe illness. Patients must start treatment within five days of symptoms.

Phase 2/3, randomized, placebo-controlled, double-blind research enroll only unvaccinated people; however, it remains unclear whether the pill could be used to treat vaccinated people with mutated infections if it were approved.

Molnupiravir has been approved for use in the UK

Read more about Merck and its COVID-19 pill:

Merck shares fall after Citi downgrades on ‘high probability’ that HIV treatment will be abandoned

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

Why a pill you take at home can change the direction of the pandemic