Merck asks FDA to authorize promising Covid-19 pill

The filing comes soon after data from a late-stage study showed that the antiviral drug, molnupiravir, reduced the risk of hospitalization or death by nearly 50% in high-risk people with mild to moderate COVID-19. does it.

The US Food and Drug Administration could clear antivirals in the coming weeks and could potentially lead to another severe cold, especially in people who haven’t been vaccinated, some public-health experts say.

Merck Chief Executive Robert Davis said, “The extraordinary impact of this pandemic demands that we proceed with unprecedented urgency, and that’s what our teams did by submitting this application for molnupiravir to the FDA within 10 days of receiving the data.” Is.”

Unlike COVID-19 vaccines and some other drugs for the disease that target the spike protein, molunpiravir works by targeting a part of the virus that helps it reproduce.

Doctors and patients are waiting for an effective pill that is easy to take at home, to prevent a case from becoming serious and requiring hospitalization.

Antibody drugs like Regeneron Pharmaceuticals Inc have been authorized for use in COVID-19 patients prior to hospitalization. These drugs have been shown to be more effective in clinical trials, but they require infusion and are difficult to administer.

The Merck-Ridgeback pill, if authorized, would be the first oral antiviral for COVID-19. A course of treatment is 40 tablets, eight daily for five days, started within five days after symptoms appear.

The companies said that the rate of side effects in study subjects who received mollupiravir and those who received a placebo were similar.

The findings were based on a preliminary look at data from an important trial that ended in November.

Merck plans to manufacture 10 million courses of treatment by the end of the year and has already started production. NJ-based drugmaker Kenilworth has struck a $1.2 billion deal with the US to provide 1.7 million courses of treatment should regulators approve it for use.

Merck has also said that it will make molnupiravir available globally and has licensing agreements with generic drug manufacturers including Dr Reddy’s Laboratories Ltd and Sun Pharmaceutical Industries Ltd to ensure availability of the drug in low-income countries.

The company also said that it plans to price molnupiravir based on World Bank norms for the funds of the country it buys, to help expand its reach to low- and middle-income countries.

Remdesivir, from Gilead Sciences Inc., is the only FDA-approved antiviral, but its use is limited to hospitalized patients.

The companies announced positive results for molnupiravir this month, when a preliminary look at the data found it helped people who were at high risk of getting sick. High risk was defined as having at least one characteristic associated with serious illness or death, such as older age, obesity or diabetes.

The emergency-use authorization requested by Merck and Ridgeback is different from full approval, which allows manufacturers to distribute products during public-health emergencies based on the best evidence available at the time.

Ridgeback licensed mollupiravir from a not-for-profit biotech company owned by Emory University and joined Merck on its development last year.

Other drugmakers working on COVID-19 antivirals include Roche Holding AG and partner Aetia Pharmaceuticals Inc., as well as Pfizer Inc., although they have yet to announce any results from the study as of late.

This story has been published without modification to the text from a wire agency feed