IQWIG rebuffs Novo's Tresiba

Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said in a preliminary benefit assessment that Tresiba insulin degludec from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) has "no additional benefit" vs. other long-acting insulins in combination with short-acting insulin to treat Type I and II diabetes. IQWiG said Novo Nordisk did not submit all relevant studies and excluded important information on the methodology and results for studies the company did include in the dossier. Novo told BioCentury that it "is not normal practice to make raw data from clinical trials public in the way IQWIG asked for."

Comments are due Aug. 22, with a final assessment from Germany's Federal Joint Committee (G-BA) expected in mid-October. ...