March 28 Quick Takes: Japan approvals include Sanofi’s Xenpozyme for rare disease

A pair of drug approvals from Japan’s Ministry of Health, Labor and Welfare includes the first authorization anywhere in the world for Xenpozyme olipudase alfa from Sanofi (Euronext:SAN; NASDAQ:SNY), indicated to treat non-CNS manifestations of acid sphingomyelinase deficiency, also known as Niemann-Pick disease types A, A/B, and B. The recombinant human acid sphingomyelinase (rhASM) is also under review in the U.S., where Sanofi expects a decision in early 3Q22; and in the EU, where a decision is due next half.

The Japanese regulator also added ulcerative colitis to the label of Jyseleca filgotinib from Gilead Sciences Inc. (NASDAQ:GILD), Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG), Eisai Co. Ltd. (Tokyo:4523) and EA Pharma Co. Ltd. The JAK-1 inhibitor was already approved to treat rheumatoid arthritis...