CMO Levi Garraway (Genentech)

Fo­cus­ing on the bright side, FDA OKs Roche's Actem­ra for rare lung dis­ease de­spite PhI­II flop

Actem­ra’s fail­ure to hit the pri­ma­ry end­point in a Phase III study didn’t stop the FDA from grant­i­ng Roche pri­or­i­ty re­view. And it’s cer­tain­ly not stand­ing in the way of a sixth ap­proval for Roche’s IL-6 drug.

Reg­u­la­tors have cleared Actem­ra, or tocilizum­ab, for sys­temic scle­ro­sis-as­so­ci­at­ed in­ter­sti­tial lung dis­ease in adult pa­tients. Roche’s big Genen­tech sub­sidiary notes that it is the first bi­o­log­ic ap­proved for this rare dis­ease.

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