Merck Asks FDA to Authorize Promising Covid-19 Pill

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The drug could meet a huge need for a pill that patients can easily take at home to help avoid hospitalization

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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.

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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 have done by submitting an application for molnupirvir to the FDA within 10 days of receiving the data.” “

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.

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Doctors and patients await an effective pill that will be easy to take at home, aiming to prevent a case from becoming severe and requiring hospitalization.

Antibody drugs like Regeneron Pharmaceuticals Inc.,

It has 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 license agreements with generic drug manufacturers, including Dr. Reddy’s Laboratories. Ltd.

and Sun Pharmaceutical Industries Ltd.

, to ensure the availability of medicine in low-income countries.

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

Remdesivir, from Gilead Sciences Inc.,

It 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 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 are working on COVID-19 antivirals, including Roche Holding . also includes AG

and partner Atia Pharmaceuticals Inc.,

as well as pfizer Inc.,

Though they have not yet announced any result from the study as of late.

Jared S. Hopkins at [email protected]


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