FDA Gives Thumbs Up to Biogen Multiple Sclerosis Pill
March 28th, 2013 // 3:54 pm @ jmpickett
- April 3 – Audit Your Lab Like an Expert FDA Auditor: A Roadmap to Lab Compliance
- April 10 – Avoid the CDRH eCopy Chaos – How to Prepare a Compliant eCopy Submission
- April 11 – The Quality Manager Gets Fired, the $100,000 Compliance SNAFU, And 21 Tips and Tricks For Your Next Audit
In one of the more eagerly awaited regulatory moves, the FDA has approved the Tecfidera multiple sclerosis pill from Biogen Idec, which Wall Street believes can eventually generated anywhere from $3 billion to $6 billion in annual sales over the next several years and easily eclipse a handful of rival treatments.
Although Tecfidera is the third MS pill to reach the US market, its safety and efficacy profile is expected to help the medication outshine other oral treatments – Gilenya, which is sold by Novartis, and Aubagio, a Sanofi (SNY) pill that was approved last fall by the FDA.
7 Tips to Hire Top GMP Consultant
Combined clinical trial data showed that Tecfidera cut the average relapse rate by 49 percent after two years compared with patients taking a placebo. And in its statement, the FDA noted that one trial showed that patients given the Biogen pill, which must be taken twice a day, experienced a worsening of their disability less often than those on a placebo (read here). “With the FDA approval of TECFIDERA, we will offer the MS community a treatment with strong efficacy and a favorable safety profile in the convenience of a pill – a combination we believe will have a significant positive impact on the way people live with this chronic disease,†said Biogen ceo George Scangos in a statement.
There was no immediate information about pricing, although Wall Street expects the pill to cost $50,000 or so per patient per year. Gilenya, for instance, costs about 60,000, while Sanofi charges $45,000 for Aubagio. Biogen (BIIB) currently charges roughly $52,500 for its older Tysabri medication.
There is no indication from the labeling that Tecfidera poses any significant safety risk, but you can read the labeling for yourself …
