Viatris and Mapi evaluate next steps after FDA rejects long-acting MS injection

The FDA hand­ed down a com­plete re­sponse let­ter to Vi­a­tris and Mapi Phar­ma for their long-act­ing in­jec­tion for the treat­ment of re­laps­ing forms of mul­ti­ple scle­ro­sis, the com­pa­nies an­nounced Mon­day.

In a state­ment with few de­tails, the com­pa­nies said they are re­view­ing the CRL and will be “de­ter­min­ing the ap­pro­pri­ate next steps,” adding that they “con­tin­ue to be­lieve in the po­ten­tial of the prod­uct to pro­vide an im­por­tant new treat­ment ad­vance­ment for pa­tients with mul­ti­ple scle­ro­sis.” Vi­a­tris said that the re­jec­tion doesn’t change its 2024 fi­nan­cial guid­ance or its new prod­uct rev­enue range of $450 mil­lion to $550 mil­lion.

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