Merck to Ask FDA for Emergency Approval of Its New Antiviral Pill for COVID

Robin Foster, HealthDay Reporter

FRIDAY, Oct. 1, 2021 (HealthDay News) -- Pharmaceutical elephantine Merck & Co. said Friday that it volition question national support for exigency usage of its caller antiviral pill molnupiravir, aft a clinical trial showed the cause halved the hazard of hospitalization oregon decease erstwhile fixed to high-risk radical soon aft corruption with COVID-19.

The caller medicine is conscionable 1 of respective antiviral pills present being tested successful studies, and experts accidental these medications could springiness doctors a almighty caller limb to conflict the virus.

"More tools and treatments are urgently needed to combat the COVID-19 pandemic, which has go a starring origin of decease and continues to profoundly impact patients, families and societies, and strain wellness attraction systems each astir the world," Merck CEO and President Robert Davis said successful a institution statement. "With these compelling results, we are optimistic that molnupiravir tin go an important medicine arsenic portion of the planetary effort to combat the pandemic."

And, helium added, "We volition proceed to enactment with regulatory agencies connected our applications and bash everything we tin to bring molnupiravir to patients arsenic rapidly arsenic possible."

Daria Hazuda, vice president of infectious diseases and vaccine find astatine Merck, told the Washington Post, "We ever believed antivirals, particularly an oral antiviral, would beryllium an important publication to the pandemic. Keeping radical retired of the infirmary is incredibly important, fixed the emergence of variants and the continued improvement of the virus."

Infectious illness experts embraced the news.

"I deliberation it volition construe into galore thousands of lives being saved worldwide, wherever there's little entree to monoclonal antibodies, and successful this country, too," Dr. Robert Shafer, an infectious illness specializer and adept connected antiviral therapy astatine Stanford University, told The New York Times.

Angela Rasmussen, a virologist and probe idiosyncratic astatine the Vaccine and Infectious Disease Organization astatine the University of Saskatchewan successful Canada, agreed that antiviral pills tin scope much radical than cumbersome antibody treatments.

"If that holds up astatine the colonisation scale, that is going to construe to an objectively larger fig of lives saved perchance with this drug," she told the Times. "Maybe it isn't doing the aforesaid [efficacy] numbers arsenic the monoclonal antibodies, but it's inactive going to beryllium huge."

Other antiviral pills successful the works

Late-stage survey results of 2 different antiviral pills, 1 developed by Pfizer and the different by Atea Pharmaceuticals and Roche, are expected wrong the adjacent fewer months, the Times reported.

In the Merck trial, which has not been peer-reviewed oregon published, molnupiravir was taken doubly a time for 5 days.

Merck said that an autarkic committee of experts monitoring its survey information recommended that the proceedings beryllium halted aboriginal due to the fact that the drug's benefits to patients were truthful convincing. The institution added that the U.S. Food and Drug Administration had agreed with that decision.

By aboriginal August, the survey had enrolled 775 volunteers successful the United States and overseas. They had to instrumentality the pills wrong 5 days of infection. For volunteers who were fixed the drug, their hazard of being hospitalized oregon dying fell by 50%, without immoderate concerning broadside effects, compared with those who received placebo pills, Merck said.

Just 7% of volunteers successful the radical that received the antiviral pills were hospitalized and nary of those patients died, compared with a 14% complaint of hospitalization and 8 deaths successful the placebo group.

Lab and carnal experiments suggest the pill whitethorn besides enactment against the Delta variant, the Post reported. Unlike vaccines oregon antibodies that people circumstantial proteins connected the aboveground of the virus, molnupiravir introduces nonsense mutations that scramble the coronavirus's familial codification truthful it can't replicate. That means it mightiness adjacent enactment connected different coronaviruses oregon RNA viruses.

Merck's pill whitethorn combat different coronaviruses

"As a virologist, that's 1 of the things I find peculiarly exciting," Hazuda told the Post. "Now, we've demonstrated the imaginable to person a cause that could enactment crossed aggregate coronaviruses. I don't deliberation this is the past pandemic successful our lifetime, and having thing readily disposable that is progressive would beryllium amazing."

The Merck pill's efficacy was little than that of monoclonal antibody treatments, which mimic antibodies that the immune system generates people erstwhile needed, the Times reported.

Those drugs person been successful precocious request recently, but they are costly and are time-consuming to administer due to the fact that they are delivered intravenously. But studies person shown that they trim hospitalizations and deaths by 70% to 85% successful high-risk patients, the Times reported.

The national authorities has already placed beforehand orders for 1.7 cardinal courses of Merck's antiviral pill, astatine a terms of astir $700 per patient, which is one-third of the existent outgo of a monoclonal antibody treatment, the Times reported.

Merck — which is processing the pill with Ridgeback Biotherapeutics of Miami — did not accidental which patients it would inquire the FDA to o.k. for the treatment.

Initially, that radical whitethorn beryllium constricted to patients who are eligible to person monoclonal antibody treatments, perchance older radical and those with aesculapian conditions that enactment them astatine precocious hazard for atrocious outcomes from COVID-19 infection. But experts noted that they expected that the cause mightiness yet beryllium utilized successful galore radical who trial affirmative for the virus, the Times reported.

If authorized, Merck's cause would beryllium the 2nd COVID-19 antiviral treatment. The first, remdesivir, indispensable beryllium infused and has mislaid favour among doctors arsenic studies person suggested it lone offers a humble benefit, the Times reported.

More information

Visit the U.S. Centers for Disease Control and Prevention for much connected COVID antivirals.