Covid pill for FDA approval | Page 3 | Sunday Observer

Covid pill for FDA approval

3 October, 2021

Pharmaceutical giant Merck & Co. said on Friday that it will seek federal approval for emergency use of its new antiviral pill molnupiravir, after a clinical trial showed the drug halved the risk of hospitalisation or death when given to high-risk people shortly after infection with Covid-19.

The new medication is just one of several antiviral pills now being tested in studies, and experts say these medications could give doctors a powerful new weapon to battle the virus.

“More tools and treatments are urgently needed to fight the Covid-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families and societies, and strain health care systems all around the world,” Merck CEO and President Robert Davis said in a company statement.

“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”

And, he added, “We will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”

Daria Hazuda, vice president of infectious diseases and vaccine discovery at Merck, told the Washington Post, “We always believed antivirals, especially an oral antiviral, would be an important contribution to the pandemic. Keeping people out of the hospital is incredibly important, given the emergence of variants and the continued evolution of the virus.”

Infectious disease experts embraced the news.

“I think it will translate into many thousands of lives being saved worldwide, where there’s less access to monoclonal antibodies, and in this country, too,” Dr. Robert Shafer, an infectious disease specialist and expert on antiviral therapy at Stanford University, told The New York Times.

Late-stage study results of two other antiviral pills, one developed by Pfizer and the other by Atea Pharmaceuticals and Roche, are expected within the next few months, the Times reported.

Source: WebMD News - HealthDay

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