COVID-19 regulatory updates

The European Medicines Agency’s human medicines committee, the CHMP, on Friday recommended the refusal of a marketing authorization for US pharma giant Merck & Co’s (NYSE: MRK) Lagevrio (molnupiravir) for the treatment of COVID-19 in adults.

The review of the  marketing authorization application for Lagevrio had started on November 23, 2021, following advice intended to support decisions at European Union member state level to enable possible early use of the medicine prior to marketing authorization. Having evaluated the interim data available at the time of the advice, and all additional data provided by the company since then, the CHMP concluded that the clinical benefit of Lagevrio in the treatment of adults with COVID-19 who are not receiving supplemental oxygen and who are at increased risk of developing severe COVID-19 could not be demonstrated.

Based on the totality of data, the EMA said it was not possible to conclude that Lagevrio can reduce the risk of hospitalization or death or shorten the duration of illness or time to recovery in adults at risk of severe disease. Furthermore, it was not possible to identify a specific group of patients in whom a clinicall- relevant benefit of Lagevrio could be demonstrated.