Sept. 21 Quick Takes: FDA nod for Incyte’s topical JAK

Atopic dermatitis patients will have a new topical treatment option now that FDA has approved Opzelura, a formulation of JAK-1/JAK-2 inhibitor ruxolitinib from Incyte Corp. (NASDAQ:INCY). The therapy is indicated for non-immunocompromised patients aged 12 and older with mild to moderate disease not adequately controlled by prescription therapies. Opzelura led to significantly clearer skin and reduced itching compared with vehicle in two Phase III trials. Incyte markets an oral version of ruxolitinib as Jakafi/Jakavi to treat myelofibrosis, polycythemia vera and graft-versus-host disease. 

With a decision due from FDA by Sept. 29 on its NDA for maralixibat to treat Alagille syndrome, Mirum Pharmaceuticals Inc. (NASDAQ:MIRM) has entered a deal granting Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) rights in Japan to the SLC10A2 inhibitor. The deal includes three rare pediatric liver disease indications: Alagille syndrome, progressive familial intrahepatic cholestasis and biliary atresia. Mirum has also submitted an MAA for maralixibat to EMA to treat Alagille syndrome...