An oral drug candidate developed by Biogen Idec Inc. and intended to improve walking ability in patients with multiple sclerosis will likely get marketing approval in Europe, the company reported today.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for conditional approval of Biogen Idec’s Fampyra, known as Ampyra in the U.S. The positive opinion stems from an appeal by Biogen, following a January report in which Fampyra got a negative opinion from European drug regulators. At the time, the EMA wrote that it “was not convinced that Fampyra’s small effect on the walking speed was a meaningful benefit for patients. The effect on speed could not be linked to meaningful improvements such as better coordination, balance or stamina or increased range of action. The committee was of the view that the medicine’s uncertain benefits did not outweigh its side effects which included pain, dizziness, paraesthesia (unusual sensations like pins and needles) and problems with balance, as well as symptoms similar to those of multiple sclerosis that could impair the patient’s ability to walk.”