As of day 29, no deaths were reported in patients receiving molnupiravir, compared with 8 deaths in patients receiving placebo.
Merck recently announced that the oral antiviral drug molnupiravir significantly reduced the risk of hospitalization or death in a planned interim analysis of the phase 3 MOVe-OUT trial.
In the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients receiving molnupiravir were hospitalized or died by day 29 after randomization (28/385), compared with 14.1% of patients treated with placebo (53/377); p = 0.0012.
As of day 29, no deaths were reported in patients receiving molnupiravir, compared with 8 deaths in patients receiving placebo. On the recommendation of an independent Data Monitoring Committee and in consultation with the US Food and Drug Administration (FDA), recruitment for the study is stopped early due to these positive results.
Merck plans to submit an Emergency Use Authorization (EUA) request to the US FDA as soon as possible based on these findings. It also plans to send marketing requests to other regulatory bodies around the world.
“More tools and treatments are urgently needed to combat the COVID-19 pandemic, which has become a leading cause of death and continues to deeply affect patients, families and societies, and puts pressure on systems. healthcare providers around the world. With these compelling results, we are optimistic that molnupiravir may become an important drug as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of delivering infectious disease breakthroughs when they are needed most. In keeping with Merck’s unwavering commitment to saving and improving lives, we will continue to work with regulatory agencies on our applications and do everything we can to get molnupiravir to patients as quickly as possible, ”said Robert M. Davis, CEO and President. , Merck.
“On behalf of all of us at Merck, I thank our network of clinical researchers and patients for their essential contributions to the development of molnupiravir,” he added.
“As the virus continues to circulate widely and because currently available therapeutic options are infused and / or require access to a healthcare facility, antiviral treatments that can be taken at home to support people with COVID-19 outside the hospital are sorely needed, ”said Wendy Holman, CEO of Ridgeback Biotherapeutics.
“We are very encouraged by the results of the interim analysis and hope that molnupiravir, if authorized for use, could have a profound impact on controlling the pandemic. Our partnership with Merck is critical to ensuring rapid global access if this drug is approved, and we appreciate the collaborative effort to reach this important stage of development, “he added.
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