Merck is planning to seek authorisation in the United States and elsewhere for an oral medication that it claims has shown “convincing results” against coronavirus in clinical trials. Molnupiravir reduced the risk of hospitalisation or death among mild or moderate cases of COVID-19 by about 50%, the German pharma giant and its US partner Ridgeback Biotherapeutics announced on Friday. An interim analysis of a phase 3 study found that 7.3% of patients treated with molnupiravir were hospitalized within 29 days, compared to 14.1% in the placebo group who were hospitalized or died by day 29.
The 775 participants were randomly assigned either molnupiravir or placebo within 5 days of the onset of COVID-19 symptoms.
All participants were unvaccinated and had at least one underlying factor such as obesity, diabetes and heart disease, that increased their risk of developing more severe cases of the virus.
The Phase 3 part of the trial was conducted at more than 170 sites in countries such as the United States, Brazil, Italy, Japan, South Africa, Taiwan and Guatemala. The results have not been peer reviewed yet, but medical experts monitoring the trial recommended stopping it early because the interim results were so strong.
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Merck CEO and President Robert M. Davis said the companies were optimistic that “molnupiravir can be an important drug as part of a global effort to combat the pandemic.”
Wendy Holman, CEO of Ridgeback Biotherapeutics, said molnupiravir could have a “significant impact on the control of the pandemic.”
Merck said it plans to seek an emergency use authorization from the Federal Drug Administration (FDA) as soon as possible. The FDA approval will pave way for the United States purchasing 1.7 million doses of the drug.
Side effects were reported by both groups in the trial, but they were slightly more common among the placebo group.
FDA-approved antiviral drug, remdesivir, and three antibody therapies that help the immune system fight the virus, have to given by IV or injection at hospitals or medical clinics.
Merck has already started production of Molnupiravir and expects10 million courses of treatment by the end of 2021 and more in 2022.