EMA’s CHMP recommends Takeda VEGF therapy, Idorsia hypertension drug

EMA’s CHMP recommended approval of five new medicines and half a dozen label expansions at its April meeting.

Highlights among the would-be new drugs include Fruzaqla fruquintinib, which CHMP recommended for metastatic colorectal cancer patients who have previously received chemotherapy. If authorized, the therapy would offer the population an oral, chemotherapy-free treatment option.  Takeda Pharmaceutical Co. Ltd. (Tokyo:4502; NYSE:TAK) licensed ex-China rights to Fruzaqla, which targets all three VEGF receptors and EGFR, from Hutchmed China Ltd. (NASDAQ:HCM; LSE:HCM; HKEX:0013). The drug was approved in China, as Elunate, in 2018; it received FDA approval in November. CHMP’s recommendation is based on the Phase III FRESCO-2 trial, which showed a median overall survival of 7.4 months vs. 4.8 months with placebo (HR=0.66; p<0.001), and progression-free survival of 3.7 months vs. 1.8 months on placebo (HR=0.32, p<0.001). ...