March 5 Quick Takes: A regulatory first for Actemra; plus updates from Lilly-Incyte, Kronos, Junshi, United Therapeutics, Pfizer, Sumitomo Dainippon, Arena, Oyster Point, Azura
The Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) said FDA approved Actemra tocilizumab to treat systemic sclerosis-associated interstitial lung disease, making it the first approved biologic for the disorder. FDA based the approval on data from the Phase III focuSSced trial, in which patients receiving Actemra had less decline in forced vital capacity than those receiving placebo. The study did not meet its primary endpoint measuring skin fibrosis. Genentech markets the mAb against the IL-6 receptor for a basket of autoimmune indications and cytokine release syndrome.
Baricitinib meets endpoint in first Phase III for alopecia areata
Eli Lilly and Co. (NYSE:LLY) and Incyte Corp. (NASDAQ:INCY) said baricitinib significantly improved scalp hair regrowth vs. placebo in the Phase III BRAVE-AA2 study of alopecia areata, meeting its primary efficacy endpoint. The JAK-1/JAK-2 inhibitor has breakthrough therapy designation in the indication, for which there are no FDA approved treatments; a second Phase III trial is to read out this half. Lilly markets baricitinib as Olumiant to treat rheumatoid arthritis...