Merck and Ridgeback Biotherapeutics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has authorised their antiviral medicine, molnupiravir, in the UK.
The drug was authorised to treat mild-to-moderate Covid-19 in adults, who are at risk of developing severe disease, and will be sold in the country as Lagevrio. It is being jointly developed by Merck and Ridgeback Biotherapeutics.
Molnupiravir was authorised based on positive results from the Phase 3 MOVe-OUT clinical trial interim analysis, which evaluated molnupiravir in 800mg twice-daily dose.
The UK regulator said that the approval follows its review of safety, quality and effectiveness and by the government’s independent expert scientific advisory body.
With the regulatory approval, molnupiravir becomes the first oral antiviral approved for the treatment of Covid-19, said MHRA.
MHRA chief executive Dr June Raine said: “Following a rigorous review of the data by our expert scientists and clinicians, we are satisfied that Lagevrio (molnupiravir) is safe and effective for those at risk of developing severe Covid-19 disease and have granted its approval.
“Lagevrio is another therapeutic to add to our armoury against Covid-19. It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously.
“This is important, because it means it can be administered outside of a hospital setting, before Covid-19 has progressed to a severe stage.”
Molnupiravir is an investigational, oral ribonucleoside analogue, created at Emory University, and was licensed to Ridgeback by Drug Innovation Ventures at Emory (DRIVE).
Last month, Merck has filed an application with the US Food and Drug Administration (FDA) seeking emergency use authorisation (EUA) for the drug.
Also, the European Medicines Agency (EMA) commenced a rolling review of molnupiravir for the treatment of Covid-19 in adults.
Merck CEO and president Robert Davis said: “The first global authorisation of molnupiravir is a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges.
“In pursuit of Merck’s unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible.”
Recently, Merck signed a licensing agreement with the Medicines Patent Pool (MPP) to enhance global access for molnupiravir.
