Shocking: Merck’s Seeking Approval For Expermintal COVID-19 Pill

Washington (AP) – On Friday, Merck & Co. stated their experimental COVID-19 pill reduced death and hospitalizations by half in those recently infected with the virus and will seek authorized use around the world.

If approved, Merck’s COVID-19 pill would be a first, a potential advance in the fight against the pandemic. All authorized COVID-19 therapies require an IV or injection.

Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and death as patients who received a placebo. The study tracked 775 adults who had mild-to-moderate COVID-19 that were considered at higher risk for health problems like obesity, diabetes, or heart disease.

Among those taking molnupiravir, 7.3% were hospitalized or died at the end of 30 days, compared with 14.1% of those taking the placebo. After the 30 days, there were no deaths of those taking the drug compared to eight deaths in the placebo group, according to Merck. The results released have not been peer review; however, Merck plans to present them in a future medical meeting.

An independent group of medical experts who monitored the trial recommended early termination as the interim results were strong. Company executives state they are in discussions with the Food and Drug Administration, and in the coming days, the data will be submitted for review.

“It exceeded what I thought the drug might be able to do in this clinical trial,” said Dr. Dean Li, vice president of Merck research. “When you see a 50% reduction in hospitalization or death that’s a substantial clinical impact.”

Reported side effects by both groups in the Merck trial were slightly more common in the group administered the placebo. The company identified no specific problems.

Those patients already hospitalized with severe disease did not show benefit from the drug, as earlier results show.

One antiviral drug has been approved in the U.S. remdesivir, specifically for COVID-19, three antibody therapies have been allowed emergency use. However, all have to be given by IV or injection at medical clinics or hospitals; the delta variant surge has stretched supplies.

Health experts have called for a convenient pill, something patients could take when symptoms appear, much like Tamiflu. A key to controlling future infections and reducing the impact of that pandemic.

Merck’s pill works by interfering with the coronavirus’s enzyme to copy its genetic code and reproduce itself. It has shown similar activity against other viruses.

The U.S. government has committed to purchase 1.7 million doses of the drug if authorized by the FDA, even though the company has not announced any pricing. Merck has said it can produce 10 million doses by the end of the year and has contracts with governments worldwide.

Similar drugs are being studied by other companies, including Pfizer and Roche, with reported results anticipated to come in weeks or months.

Merck had planned to enroll more than 1,500 patients in its late-stage trial before the independent board early termination. The results reported Friday included patients enrolled across Latin America, Europe, and Africa. Executives estimated about 10% of patients studied were from the U.S.