Filenews 18 October 2021
Production of about 10 million. Treatment cycles from the drug molupiravir announced that the pharmaceutical company Merck, Sharp & Dohme (MSD) is starting by the end of 2021, with more doses to be produced in 2022.
Production is progressing pending the results of the MOVe-OUT clinical study, as well as the possible licensing of the drug by international regulatory agencies (already yesterday MSD in collaboration with Ridgeback Biotherapeutics submitted an application for approval by the US Food and Drug Administration FDA for An Emergency Use License).
Alongside the application for licensing, U.S. pharmaceuticals began agreements to supply the drug with governments of various states, internationally.
According to the data so far, molupiravir is an antiviral drug administered orally, for the treatment of mild to moderate COVID-19 disease in adults at risk of developing severe COVID-19 disease or even hospitalization. In terms of its effectiveness, the medicine reduced the risk of hospitalization or death by about 50%.
The submission of the application for approval was based on the positive results from a planned interim analysis of the data of the Phase 3 clinical trial, MOVe-OUT. This analysis evaluated molupiravir in untreated adults with mild to moderate COVID-19 disease, who are at risk of severe COVID-19 disease or hospitalization.
As stated by MSD's chairman and CEO, Robert M. Davis, "The great impact of this pandemic requires us to react urgently, and this is what our teams did by submitting the application for FDA approval of the drug within 10 days of receiving the clinical data. We are grateful to the patients and researchers who participated in our study, and of course to the colleagues who have shown high standards of MSD's scientific excellence and our unwavering commitment to patients." Mr. Davis congratulated the company's pharmaceutical industry workers and partners in the global research community who have risen to the challenge of developing drugs and vaccines to fight COVID-19, noting that "drugs and vaccines are both essential to our collective efforts.
We look forward to working with the FDA to evaluate our application and working with other regulatory agencies as we do everything we can to bring Molupiravir to patients around the world as quickly as possible."
Meanwhile, according to international agencies, Roche, Pfizer and Appili Therapeutics are expected to complete phase 3 clinical trials for oral anti-coronavirus drugs in the coming weeks.
