BioCentury
ARTICLE | Company News

CHMP recommends basket of therapies

December 15, 2017 11:22 PM UTC

EMA's CHMP recommended approval of a host of therapies, including Alofisel darvadstrocel (Cx601) to treat Crohn's disease, Ozempic semaglutide (NN9924, OG217SC) to treat Type II diabetes, Herzuma biosimilar trastuzumab to treat breast and gastric cancer and Crysvita burosumab (KRN23, UX023) to treat X-linked hypophosphataemia (XLH). The committee did not recommend approval of Aplidin plitidepsin to treat multiple myeloma (MM).

CHMP backed approval of Alofisel from TiGenix N.V. (Euronext:TIG; NASDAQ:TIG) and Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to treat complex perianal fistulas in patients with Crohn’s disease. In 2016, TiGenix granted Takeda exclusive rights to develop and commercialize the allogeneic expanded adipose derived stem cell therapy outside of the U.S. EU approval will trigger a €15 million ($17.7 million) milestone payment to TiGenix (see BioCentury Extra, July 5, 2016)...