FDA Review Panel Extends The Review Period of Biogen Idec’s MS Drug

The FDA just announced that they are extending the review period of Biogen Idec’s MS drug, BG-12, by three months. The FDA extended three months past the original deadline of December 28. Biogen said that this three month extension is normal and that the FDA did not request any additional studies. If approved, BG-12 will be an alternative to Novartis’ MS drug, Gilenya. Later this year, the ALS Therapy Development Institute plans to launch a Phase II clinical trial testing the safety and tolerability of Gilenya in people with ALS. Perhaps Biogen will consider testing BG-12 in ALS?

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