Firm plans to appeal and request a re-examination.
The European regulatory agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended against the approval of Biogen Idec’s Fampyra® (prolonged-release fampridine 10 mg tablets), as a therapy to help improve walking ability in patients with multiple sclerosis (MS). The firm says it will appeal the opinion and ask the CHMP to re-examine the submission.
“We will work closely with the CHMP during the appeal process to address the committee’s concerns, with the goal of making this important medication available to MS patients in Europe,” notes Alfred Sandrock, M.D., Biogen Idec’s head of neurology R&D.
Biogen Idec’s drug is not the only MS candidate to fail CHMP scrutiny within the last 24 hours. Merck KGgA has separately confirmed that the committee has upheld its previously negative opinion on Cladribine, and will not recommend approving the oral therapy based on existing data. Novartis was the only company to get a positive recommendation from CHMP on its MS medication, Gilenya.
Biogen Idec is developing prolonged-release fampridine for non-U.S. markets under license from Acorda Therapeutics. The drug was approved by the FDA in January 2010, under the trade name Ampyra™ and launched commercially by Acorda in the U.S. in March. The firm says that as of September 30, 2010, approximately 6,300 U.S. physicians had prescribed Ampyra to approximately 31,000 people with MS.
The CHMP says it could not recommend approving Fampyra in the EU because it was not convinced that the drug’s small effect on walking speed was a meaningful benefit for patients.
According to EMA, “the committee was of the view that the medicine’s uncertain benefits did not outweigh its side effects, which included pain, dizziness, paraesthesia, and problems with balance, as well as symptoms similar to those of multiple sclerosis that could impair the patient’s ability to walk. The committee also noted the lack of adequate long-term data on the medicine’s benefits and safety as well as data on some groups of patients, such as the elderly and patients with epilepsy or heart problems.”