Merck asks FDA to clear promising Covid-19 pill

The United States Food and Drug Administration could eliminate the antiviral in the coming weeks and perhaps in time for what some public health experts say could be another bitter winter, especially in people who are not. vaccinated.

“The extraordinary impact of this pandemic demands that we act with unprecedented urgency, and that is what our teams have done by submitting this molnupiravir request to the FDA within 10 days of receiving the data,” said Merck Managing Director Robert Davis.

Unlike Covid-19 vaccines and some other disease medications that target the spike protein, molnupiravir works by targeting a part of the virus that helps it reproduce.

Doctors and patients were waiting for a pill that was effective and easy to take at home, in an effort to prevent a case from worsening and requiring hospitalization.

Antibodies, such as that from Regeneron Pharmaceuticals Inc.,

were cleared for use in Covid-19 patients prior to hospitalization. These drugs have been shown to be more effective in clinical trials, but they require infusions and are more difficult to administer.

The Merck-Ridgeback pill, if authorized, would be the first oral antiviral against Covid-19. One course of treatment is 40 tablets, eight a day for five days, started within five days of the onset of symptoms.

The companies said the rate of side effects in study subjects who received molnupiravir and those who received placebo was similar.

The results were based on a first look at data from a pivotal trial scheduled to end in November.

Merck plans to manufacture 10 million treatments by the end of the year and has already started production. The Kenilworth, New Jersey-based drugmaker has reached a $ 1.2 billion deal with the United States to provide 1.7 million treatments, if regulators allow its use.

Merck has also said it will make molnupiravir available worldwide and has entered into licensing deals with generic drug makers, including Dr Reddy’s labs. Ltd.

and Sun Pharmaceutical Industries Ltd.

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

The company also said it plans to align the price of molnupiravir with the wealth of the country purchasing it, based on World Bank criteria, to help expand access for low- and middle-income countries. .

Remdesivir, from Gilead Sciences Inc.,

is the only antiviral approved by the FDA, but its use is limited to hospitalized patients.

The companies announced positive results for molnupiravir this month after an initial review of the data found it was helping unvaccinated 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 old age, obesity or diabetes.

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

Ridgeback licensed molnupiravir to a nonprofit biotech company owned by Emory University and last year partnered with Merck for its development.

Other drugmakers are working on Covid-19 antivirals, including Roche Holding AG

and partner Atea Pharmaceuticals Inc.,

as well as Pfizer Inc.,

although they have yet to announce the results of the late stage studies.

Write to Jared S. Hopkins at [email protected]