#16,243
Over the past couple of weeks there has been a lot of news about Molnupiravir, a drug developed by Merck and Ridgeback - originally designed to treat Equine encephalitis - but which has been found to have antiviral properties against coronaviruses.A week ago, this report in the BMJ summarized promising early clinical trial findings on mild-to-moderately ill adults.
Covid-19: Molnupiravir reduces risk of hospital admission or death by 50% in patients at risk, MSD reports
BMJ 2021; 375 doi: https://doi.org/10.1136/bmj.n2422 (Published 04 October 2021)Cite this as: BMJ 2021;375:n2422
But, as reported by Nature on October 8th, in How antiviral pill molnupiravir shot ahead in the COVID drug hunt, two independent studies conducted in India (on more severely ill patients) failed to find the same benefit (see Reuters Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19).
Today, Merck formally asked the FDA for An EUA for the drug, with the narrow labeled use `. . . for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.'
Admittedly, an effective oral medication that could be taken at home - early in an infection - would be a potential game changer, at least for countries that can afford it. FDA approval - if it is granted - will likely take weeks or even months in order give time to scrutinize the data.
Excerpts from this morning's press release by MERCK follow.
Merck and Ridgeback Announce Submission of Emergency Use Authorization Application to the U.S. FDA for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of Mild-to-Moderate COVID-19 in At Risk Adults
October 11, 2021 6:00 am ET
If Authorized, Molnupiravir Could Be the First Oral Antiviral Medicine for the Treatment of COVID-19
Submissions to Regulatory Agencies Worldwide Underway
KENILWORTH, N.J. & MIAMI--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that Merck has submitted an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) for molnupiravir, an investigational oral antiviral medicine, for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization. The companies are actively working with regulatory agencies worldwide to submit applications for emergency use or marketing authorization in the coming months.
The submission is based on positive results from a planned interim analysis from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir in non-hospitalized adult patients with mild-to-moderate COVID-19 who were at risk for progressing to severe COVID-19 and/or hospitalization. At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1% of placebo-treated patients (53/377); p=0.0012. Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to 8 deaths in patients who received placebo. The incidence of any adverse event was comparable in the molnupiravir and placebo groups (35% and 40%, respectively). The incidence of drug-related adverse events was also comparable (12% and 11%, respectively), and fewer subjects in the molnupiravir group discontinued therapy due to an adverse event compared to the placebo group (1.3% and 3.4%, respectively).
“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,” said Robert M. Davis, chief executive officer and president, Merck. “We are grateful to the patients and investigators in our study, and of course to our own colleagues who have exemplified Merck’s high standards of scientific excellence and our unwavering commitment to patients. I also want to take this moment to applaud our colleagues in the pharmaceutical industry and our collaborators in global health for rising to the challenge of bringing forward medicines and vaccines to fight COVID-19 — medicines and vaccines are both essential to our collective efforts. We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”
“We are grateful to the clinical investigators and patients who have helped bring us to this important milestone. Without their significant contributions, today’s achievement would not be possible. The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics. “We are pleased to partner with Merck and regulatory authorities to help provide molnupiravir to the people who need it here in the U.S. and around the world.”
(Continue . . . )
