Biogen-Idec is submitting its multiple sclerosis drug BG-12 for formal FDA scrutiny. The oral treatment is intended for relapsing-emitting MS. The company is also setting the twice- or three-times daily drug before the European Medicines Agency over the next few days. If approved, it would be Biogen’s third entry into the space — the drugmaker also markets Avonex and Tysabri. BG-12 would be only the second of the nine available therapies that is not an injection or an infusion, after Novartis’ Gilenya. “There is still a significant unmet need for new and innovative therapies that target the disease in different ways,” Biogen president of R&D Douglas Williams, PhD., said in a statement.
The FDA is being hush-hush about its agenda for an upcoming meeting of its Cardiovascular and Renal Drugs Advisory Committee, set for May 23, but the Sanford Bernstein analyst Tim Anderson, MD, has a strong suspicion that Bristol-Myers Squibb/Pfizer’s Eliquis will be discussed. If so, predicted Anderson, this could suggest a delay in the approval of Eliquis beyond its current March 28th PDUFA. That’s despite the agency’s having granted the investigational drug, which many expect will become the front-frunner in the new crop of blood thinners, six-month priority review status. “Our best guess remains that FDA may be seeking cover,” Anderson wrote in an investor note today, given safety issues with Boehringer Ingelheim’s Pradaxa, a related drug approved in 2010. Product labeling and claims could also be up for discussion. At any rate, a small delay shouldn’t hurt Eliquis’ commercial prospects much. Anderson predicts sales of $395M in 2012, ramping to $2.5B in 2015 and $3.7B by 2020.
