Merck’s Molnupiravir reduces hospitalisation risk in COVID patients, says study

If authorised, Molnupiravir could be the first oral anti-viral medicine for COVID-19
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Merck yesterday announced that Molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalisation or death at a planned interim analysis of the phase-III MOVe-OUT trial in at risk, non-hospitalised adult patients with mild-to-moderate COVID-19.

In a statement, the company said that at the interim analysis, Molnupiravir reduced the risk of hospitalisation or death by approximately 50 per cent; 7.3 per cent of patients who received Molnupiravir were either hospitalised or died through day-29 following randomisation (28/385), compared with 14.1 per cent of placebo-treated patients (53/377); p=0.0012.

It further said that through day-29, no deaths were reported in patients who received Molnupiravir, as compared to eight deaths in patients who received placebo. At the recommendation of an independent Data Monitoring Committee and in consultation with the US Food and Drug Administration (FDA), recruitment into the study is being stopped early due to these positive results. Merck plans to submit an application for Emergency Use Authorisation (EUA) to the FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide.

“More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families and societies and strain healthcare systems all around the world. With these compelling results, we are optimistic that Molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed the most. Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring Molnupiravir to patients as quickly as possible,” said Robert M Davis, Chief Executive Officer and President, Merck.

Adding to it, Wendy Holman, Chief Executive Officer, Ridgeback Biotherapeutics, said, “With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, anti-viral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed. We are encouraged by the results from the interim analysis and hope Molnupiravir, if authorised for use, can make a profound impact in controlling the pandemic. Our partnership with Merck is critical to ensure rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”

clinical trialCOVID-19 medicineMerck PharmaceuticalsmolnupiravirUS FDA
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