EMA to offer recommendation on national use for Merck's molnupiravir

Regulatory NewsRegulatory News | 08 November 2021 |  By 

The European Medicines Agency (EMA) on Monday announced it is reviewing Merck Sharp & Dohme and Ridgeback Biotherapeutics' antiviral drug Lagevrio (molnupiravir) to treat COVID-19 in an effort to provide guidance on the drug's use to national authorities prior to its EU-wide authorization.
The review, which is being conducted under Article 5(3) of Regulation (EC) No 726/2004, will allow the agency to provide a harmonized scientific opinion on the use of the molnupiravir in a shorter timeframe than a formal review would allow to facilitate the drug's emergency use on a national level.
Interim results from a Phase III trial reported last month showed the drug, which is administered orally, reduced the risk of hospitalization and death by about 50% in patients with mild to moderate COVID-19 compared to those given a placebo.
EMA said it and the Heads of Medicines Agencies (HMA) "have agreed on the need for additional guidance on COVID-19 treatments in light of rising rates of infection and deaths due to COVID-19 across the EU." The review was requested by EMA's Executive Director Emer Cooke following discussions with the EMA COVID-19 pandemic task force and will be carried out by the Committee for Medicinal Products for Human Use (CHMP).
The announcement comes two weeks after the agency began a rolling review of the drug based on the preliminary results of preclinical and clinical studies of the drug in advance of the company's submission of a formal marketing authorization application (MAA). The news also follows the UK's Medicines and Healthcare products Regulatory Agency's decision to approve the drug last week, making it the first nation in the world to do so.
On 30 November, the US Food and Drug Administration’s (FDA) vaccines advisory committee is scheduled to meet to review Merck and Ridgeback’s emergency use authorization request for molnupiravir.
EMA has relied on Article 5(3) reviews for several other medicines throughout the pandemic, including for multiple COVID-19 antibody treatments and the corticosteroid dexamethasone to treat hospitalized COVID-19 patients who require supplemental oxygen or mechanical ventilation.


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