Covid: Merck seeks FDA emergency use authorization for Monulpiravir

Published by Laurent P., Graziella L. · Updated on 12 October 2021 at 10h44 · Published on 12 October 2021 at 08h31
Good news amid the fight against Covid! Drugmakers Merck and Ridgeback Bio have announced in April their molnupiravir therapy against the virus led to promising results. This Monday October 11? 2021, the company has announced they are seeking FDA emergency use authorization for this oral drug.

Is molnupiravir an effective Covid therapy? So tell the first conclusions reported this Saturday March 6 by drugmaker Merck and pharmaceutical company Ridgeback Bio, in a release. They stated the medication – given orally – can reduce and even delete coronavirus viral load in a matter of days. “At a time where there is unmet need for antiviral treatments against SARS-CoV-2, we are encouraged by these preliminary data”, Dr. Wendy Painter, Chief Medical Officer of Ridgeback Biotherapeutics explains. The study has been released in the American Society for Microbiology since then.

We continue to make progress in our Phase 2/3 clinical programs evaluating molnupiravir in both outpatient and hospital settings and plan to provide updates when appropriate,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. As for these preliminary data - presented during the Conference on Retroviruses and Opportunistic Infections (CROI) that took place from March 6 to 10, 2021 - they are rather clear: in 202 non-hospitalized patients included in the 2a phase of the clinical trials, they have all seen “quicker decrease in infectious virus” in five days, lead investigator of the study and University of North Carolina Professor of Medicine Dr. William Fischer explains.

He goes on: “if supported by additional studies, could have important public health implications, particularly as the SARS-CoV-2 virus continues to spread and evolve globally”. As the clinical trial phase 3 is now over, leading to highly encouraging results (with an hospitalization or death rate of 7.3% against 14.1% in those given a placebo), and the company announced this Monday October 11, they are seeking FDA marketing approval for emergency use, for this therapy that could be the first one to cure Covid-19.

"The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data", Merck CEO and President Robert Davis said in the statement. He added they are "actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months".

Note Merck is also working on Covid cure, MK-711, and which clinical trials are just as promising since back to late January, searchers stated in a release they noticed a 50% decrease in death risk and breathing failure in hospitalized patients included in the trial. For the record, the German laboratory also announced several weeks ago they were stopping clinical trials on two vaccines as preliminary data were not conclusive.

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