China approves Novo's Tresiba

China FDA approved once-daily Tresiba insulin degludec (NN1250) from Novo Nordisk A/S (CSE:NOVOB; NYSE:NVO) to treat Type I and II diabetes. The pharma expects to launch the long-acting insulin analog in China in 1Q18, but declined to disclose whole sales prices.

Novo Nordisk told BioCentury the approval was based on data from the double-blind Phase IIIb SWITCH 1 and 2 trials comparing Tresiba to Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY) and the Phase III DEVOTE cardiovascular outcomes trial, as well as a Chinese pharmacokinetic study (see BioCentury, Dec. 9, 2016)...