FDA approves Ampyra
ROCKVILLE, Md. The Food and Drug Administration has approved a new drug for improving walking ability in adults with multiple sclerosis, the agency announced Friday.
The FDA approved Acorda Therapeutics’ Ampyra (dalfampridine) extended-release tablets, designed to be administered in daily 10-mg doses. The agency’s approval was based on clinical trials that showed patients treated with the drug had faster walking speeds than those who received placebo. Ireland-based Elan will manufacture the drug using its technology platform, while Acorda will market it in the United States. Biogen Idec will market it in other countries.
“Trouble with walking is one of the most debilitating problems people with MS face,” FDA Center for Drug Evaluation and Research Division of Neurology Products director Russell Katz said.
Roche seeks to make injectable device for Herceptin
BASEL, Switzerland Roche is investing 190 million Swiss francs (U.S. $182 million) into production of a new device that will allow self-administration of one of its breast cancer drugs, the Swiss drug maker announced Wednesday.
The company said the device uses Halozyme Therapeutics’ “Enhanze” technology to allow patients taking Herceptin (trastuzumab) to administer a formulation of the drug themselves without infusion by injecting it into the tissue under the skin. The drug is normally administered by infusion. Infusion takes an hour, but subcutaneous injection takes around five minutes.
Roche said the money would go into production sites in Kaiseraugst, Switzerland, and Mannheim, Germany. A phase 3 clinical trial evaluating the formulation is ongoing.
“We always strive to improve our products and manufacturing technologies, which in turn benefit our patients,” Roche Pharma Global Technical Operations head Pat Yang said. “This innovative formulation and the associated new device are designed to simplify patients’ lives.”
Clinical trial finds Novartis drug reduces progression of MS
BASEL, Switzerland An investigational drug for treating multiple sclerosis reduced progression of disability by more than 30%, according to results of a late-stage clinical trial recently published in The New England Journal of Medicine.
Novartis conducted two phase 3 trials of FTY720 (fingolimod), an oral treatment for MS, administering 0.5-mg and 1.25-mg doses to more than 2,300 patients. The Swiss drug maker applied for approval of the 0.5-mg dose with the Food and Drug Administration in December on account of its posing lower risk to patients.
In one study, which enrolled 1,272 patients and lasted for two years, patients taking the 0.5-mg dose experienced reductions in the risk of three-month and six-month confirmed disability progression by 30% and 37% compared with placebo, respectively, and got similar results from the 1.25-mg dose. In the one-year study, which enrolled 1,292 patients, the 0.5 mg dose reduced relapses by 52% compared with Biogen Idec’s Avonex (interferon beta-1a), while the 1.25-mg dose reduced them by 38%.
“Innovative science leading to new medicines for MS patients is greatly needed,” National Multiple Sclerosis Society EVP research and clinical programs John Richert said in a statement. “The positive results published in The New England Journal of Medicine showing benefit of fingolimod on the clinical and MRI outcomes assessed is very encouraging to MS patients, their families and their physicians.”