Mer­ck asks EMA to reeval­u­ate re­ject­ed Covid-19 an­tivi­ral

Mer­ck is seek­ing a reeval­u­a­tion of the Eu­ro­pean Med­i­cines Agency’s (EMA) re­jec­tion of the phar­ma’s block­buster Covid-19 pill, known as Lagevrio (mol­nupi­ravir), which has served as a sec­ond op­tion to Pfiz­er’s Paxlovid (nir­ma­trelvir/ri­ton­avir).

The EMA an­nounced its long-await­ed re­jec­tion in late Feb­ru­ary, say­ing pub­licly:

Based on the to­tal­i­ty of da­ta, it was not pos­si­ble to con­clude that Lagevrio can re­duce the risk of hos­pi­tal­i­sa­tion 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 clin­i­cal­ly rel­e­vant ben­e­fit of Lagevrio could be demon­strat­ed.

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Principal

Alexandria Real Estate Equities

Cambridge, MA, USA