Biogen’s Tecfidera Hit At NICE By Data Shortage, Functional Unblinding
This article was originally published in The Pink Sheet Daily
NICE has demanded more data and analyses for Biogen Idec’s MS champion, Tecfidera, before it clears a drug expected to be a worthy opponent for Novartis’ Gilenya.
You may also be interested in...
Genzyme had a mixed few days with its MS drugs at NICE, with Aubagio finally succeeding but Lemtrada struggling on the back of a tough benefit/risk profile.
The company expects dimethyl fumarate’s strong efficacy and favorable safety and tolerability profile to be an advantage against other oral multiple sclerosis drugs.
It is becoming ever more clear that the overriding factor in NICE’s decision-making process is a desire to see cost-effectiveness, irrespective of the clinical benefit of a drug. But in Germany, companies are challenged by IQWiG’s tightened-up, science-based review system.