Merck and Ridgeback Announce Initiation of a Rolling Review by the European Medicines Agency for Molnupiravir, an Investigational Oral Antiviral Medicine, for the Treatment of COVID-19 in Adults

If Granted Marketing Authorization by the European Commission, Molnupiravir Could Be the First Oral Antiviral Medicine for the Treatment of COVID-19 in the European Union

Merck known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics moment blazoned that the European Medicines Agency (EMA) has initiated a rolling review for molnupiravir, an investigational oral antiviral drug, for the treatment of COVID-19 in grown-ups. Merck plans to work with the EMA’s Committee for Medicinal Products for Human Use (CHMP) to complete the rolling review process to grease initiating the formal review of the Marketing Authorization Operation. As preliminarily blazoned, Merck has submitted an operation for Emergency Use Authorization (EUA) to theU.S. Food and Drug Administration (FDA), and is laboriously working to submit operations to other nonsupervisory agencies worldwide.

“ This operation to the EMA is another step in our sweats to bring molnupiravir forward to cases encyclopedically,” saidDr. DeanY. Li, administrative vice chairman and chairman, Merck Research Laboratories. “ We believe that molnupiravir will be an important addition to the range of public health tools to fight COVID-19 – including the vaccines developed by the exploration- grounded pharmaceutical assiduity, which remain essential and are the first- line of defense against this epidemic.”

“ In the nearly two times since COVID-19 surfaced, the global scientific community has made extraordinary strides in developing several critical vaccines and treatments, but we still have a need for an oral antiviral drug that can be taken at home,” said Wendy Holman, principal administrative officer, Ridgeback Biotherapeutics. “ We believe that molnupiravir, with the instigative finding of reduction in hospitalization and death in the MOVe- OUT study, may help fill that need and look forward to working with the EMA on its review.”

About Merck’s Sweats to Enable Global Access to Molnupiravir, if it’s Granted Authorization or Blessing
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In expectation of the results from MOVe- OUT and the eventuality for nonsupervisory authorization or blessing, Merck has been producing molnupiravir at threat and expects to produce 10 million courses of treatment by the end of 2021, with indeed further courses anticipated to be produced in 2022.

Before this time, Merck entered into a procurement agreement with theU.S. Government under which the company will supply roughly1.7 million courses of molnupiravir to theU.S. Government following EUA or blessing from theU.S. FDA. Also, Merck has entered into force and advance purchase agreements for molnupiravir with other governments worldwide, pending nonsupervisory authorization, and is presently in conversations with fresh governments.

Merck is committed to furnishing timely access to molnupiravir encyclopedically, if it’s authorized or approved, and plans to apply a tiered pricing approach grounded on World Bank country income criteria that reflect countries’ relative capability to finance their health response to the epidemic.

As part of its commitment to wide global access, Merck preliminarily blazoned that the company has entered intonon-exclusive voluntary licensing agreements for molnupiravir with established Indian general manufacturers to accelerate vacuity of molnupiravir in further than 100 low-and middle- income countries (LMICs) following blessings or exigency authorization by original nonsupervisory agencies. Merck continues to bandy fresh measures and collaborations to accelerate broad, global access to molnupiravir.

About Molnupiravir

Molnupiravir (MK-4482 and EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several preclinical models of SARS-CoV-2, including for prophylaxis, treatment, and forestallment of transmission. Also,pre-clinical and clinical data have shown molnupiravir to be active against the most common SARS-CoV-2 variants.

Molnupiravir was constructed at Medicine Inventions at Emory ( DRIVE), LLC, a not-for- profit biotechnology company wholly possessed by Emory University; Emory/ DRIVE entered some exploration backing from theU.S. Department of Defense and theU.S. National Institutes of Health. Molnupiravir is being developed by Merck &Co.,Inc. in collaboration with Ridgeback Biotherapeutics. Ridgeback entered an outspoken payment from Merck and also is eligible to admit contingent payments dependent upon the achievement of certain experimental and nonsupervisory blessing mileposts. Any gains from the collaboration will be resolve between the mates inversely. Since certified by Ridgeback, all finances used for the development of molnupiravir have been handed by Merck and by Wayne and Wendy Holman of Ridgeback.

Molnupiravir is also being estimated forpost-exposure prophylaxis in MOVe-AHEAD, a global, multicenter, randomized, double-eyeless, placebo- controlled Phase 3 study, which is assessing the efficacity and safety of molnupiravir in precluding the spread of COVID-19 within homes.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is a biotechnology company concentrated on arising contagious conditions. Ridgeback requests EbangaTM for the treatment of Ebola and has a late- stage development channel which includes molnupiravir for the treatment of COVID-19. Development of molnupiravir is entirely funded by Ridgeback Biotherapeutics and Merck &Co., Inc. All equity capital in Ridgeback Biotherapeutics, LP began from Wayne and Wendy Holman, who are committed to investing in and supporting medical technologies that will save lives. The platoon at Ridgeback is devoted to working toward chancing life-saving and life- changing results for cases and conditions that need titleholders.

About Merck
For over 130 times, Merck, known as MSD outside the United States and Canada, has been contriving for life, bringing forward drugs and vaccines for numerous of the world’s most grueling conditions in pursuit of our charge to save and ameliorate lives. We demonstrate our commitment to cases and population health by adding access to health care through far- reaching programs, programs and hookups. Moment, Merck continues to be at the van of exploration to help and treat conditions that hang people and creatures – including cancer, contagious conditions similar as HIV and Ebola, and arising beast conditions – as we aspire to be the premier exploration-ferocious biopharmaceutical company in the world.

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