An American company, Merck has developed a COVID-19 drug that reduces the risk of hospitalization or death by around 50% for patients with mild or moderate symptoms.
There's a new COVID-19 oral drug that reduces risk of death by 50%
10 million pills to be produced by the end of 2021.
The drug, molnupiravir, is administered orally and works by inhibiting the replication of the coronavirus inside the body.
The company plans to seek emergency authorization for the antiviral COVID-19 treatment after the medicine showed “compelling results” in clinical trials.
An interim analysis of a phase 3 study found that 7.3% of patients treated with molnupiravir were hospitalized within 29 days. Of the patients who received a placebo, 14.1% were hospitalized or died by day 29.
No deaths were reported in patients who were given molnupiravir within the 29-day period, while eight deaths were reported in placebo-treated patients.
All 775 trial participants had laboratory-confirmed symptomatic Covid-19 and were randomly given molnupiravir or a placebo within five days of symptoms.
Every participant was unvaccinated and had at least one underlying factor that put them at greater risk of developing a more severe case of the virus. The most common risk factors included obesity, being over the age of 60 and having diabetes or heart disease.
The phase 3 part of the trial was conducted at more than 170 sites, in countries including the U.S., Brazil, Italy, Japan, South Africa, Taiwan and Guatemala.
Molnupiravir’s efficacy was not affected by the timing of symptom onset or patients’ underlying risk factors, the study showed.
It also proved to be consistently effective in treating all variants of COVID-19, including the widely dominant and highly transmissible delta strain.
Adverse events were comparable in the molnupiravir and placebo groups, with around 10% reporting adverse events. Just 1.3% of the molnupiravir group discontinued therapy due to an adverse event — less than the 3.4% of the placebo group who did so.
Recruitment into the study is being stopped early due to the positive results, at the recommendation of an independent Data Monitoring Committee and in consultation with the U.S. Food and Drug Administration (FDA).
Merck is also testing molnupiravir in a separate global phase 3 study to evaluate its efficacy in preventing the spread of COVID-19 within households.
Robert M. Davis, CEO and president of Merck, said in a press release Friday that the company would do everything it can to bring molnupiravir to patients as quickly as possible.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global efforts to fight the pandemic,” he said.
Merck said it plans to seek emergency use authorization for the drug in the U.S. as soon as possible. The company also plans to submit marketing applications to other international drug regulators.
If authorized by regulatory bodies, molnupiravir could be the first oral antiviral medicine for COVID-19. Antiviral treatments now in use, such as remdesivir, are administered intravenously.
Merck has already begun producing molnupiravir. The pharmaceutical giant expects to produce 10 million courses of treatment by the end of 2021, and more doses in 2022.
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