Key Developments For Acorda Therapeutics, Inc.
Acorda Therapeutics, Inc. (ACOR.O) (Consolidated Issue listed on NASDAQ Global Market)
Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date To January 22, 2010
Acorda Therapeutics announced that U.S. Food and Drug Administration (FDA) has extended the PDUFA goal date for its review of the New Drug Application (NDA) for Fampridine-SR to January 22, 2010. The original Prescription Drug User Fee Act (PDUFA) date for this priority review application was October 22, 2009. Following the Peripheral and Central Nervous System Drugs Advisory Committee meeting on Fampridine-SR, Acorda submitted additional information on its proposed Risk Evaluation and Mitigation Strategy (REMS) program. The FDA accepted this submission as a solicited major amendment to the Fampridine-SR NDA. The FDA has the option to extend the PDUFA goal date when a sponsor submits a major amendment that provides a substantial amount of new data not previously reviewed by the FDA.
Acorda Therapeutics Announces Positive Vote By FDA Advisory Committee For Fampridine SR
Acorda Therapeutics announced that the U.S. Food and Drug Administration (FDA) Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to 1 that clinical data on Fampridine-SR 10 mg twice daily demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with multiple sclerosis (MS) and voted 10 to 2 (1 abstention) that it is clinically meaningful and can be safe for use. The Committee also recommended by a vote of 12 to 1 that Acorda be required to evaluate the effects of doses lower than 10 mg twice daily, but by a 10 to 2 vote (1 abstention) that these studies not be required prior to approval. At the request of the FDA, the Committee discussed possible conditions for use, including for patients with renal impairment or history of seizure. Acorda has proposed a Risk Evaluation and Mitigation Strategy (REMS) program, which could include healthcare professional and patient education around appropriate use of Fampridine-SR.
FDA Panel Says Data Show Proposed Acorda Therapeutics MS Drug Effective-DJ
Dow Jones reported that a Food and Drug Administration panel said a proposed Acorda Therapeutics drug to treat multiple-sclerosis appeared to be effective at increasing walking speed. The drug, fampridine-SR, is being reviewed Wednesday by an outside panel of medical experts. The panel voted 12 to 1 in favor of a question that asked if the Company demonstrated substantial evidence of effectiveness of fampridine as a treatment to improve walking in patients with multiple sclerosis. The panel is currently discussing whether the improvement is clinically meaningful and whether the product is safe. Fampridine has been associated with a seizure risk at higher doses than the 10-milligram dose for which Acorda Therapeutics is seeking FDA approval. The FDA said one study of about 300 patients showed that 34.8% of patients receiving fampridine-SR had an improvement in walking speed compared to 8.3% in the placebo group. Patients were timed as part of a 25-foot walking test at different time points during treatment. Another study involving 237 patients showed 42.9% of patients in the fampridine group had an improvement in walking speed compared to 9.3% of patients in the placebo group. But an agency reviewer said the improvement in walking speed is of small magnitude and of uncertain clinical significance.
Acorda Therapeutics Announces Posting of Briefing Documents For October 14 FDA Advisory Committee Meeting On Fampridine-SR
Acorda Therapeutics announced that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the Peripheral and Central Nervous System Drugs Advisory Committee meeting to review Acorda's New Drug Application (NDA) for Fampridine-SR for the proposed indication of improvement of walking ability in people with multiple sclerosis (MS). The Prescription Drug User Fee Act (PDUFA) action date for the Fampridine-SR NDA is October 22, 2009.
Acorda Therapeutics Announces Data On Retention Rates And Safety From Two Phase 3 Fampridine-SR Extension Studies
Acorda Therapeutics announced that data from two long-term open-label extension studies of Fampridine-SR show that 86.0% of participants remained on therapy after a maximum treatment time of 15 months in study MS-F204EXT, and 69.5% remained on therapy after a maximum treatment time of 36 months in study MS-F203EXT. The average treatment time for all patients was 10 months in the MS-F204EXT study and 26 months in the MS-F203EXT study, both inclusive of dropouts. The EFNS poster presentation inadvertently reported maximum treatment times for both studies as the median treatment times. The types of adverse events reported in the two extensions studies were consistent with the expected adverse event profile in people with more advanced multiple sclerosis (MS) and were similar between the two studies. These extension studies followed double-blind, placebo-controlled Phase 3 studies of Fampridine-SR, MS-F203 and MS-F204, in people with MS to improve walking ability. The cut-off date for the EFNS analysis was November 30, 2008, which was the cut-off for the analyses used in the Company's New Drug Application (NDA) filing for Fampridine-SR earlier this year. As of this date, the approximate total exposure to Fampridine-SR was 565 patient-years in the MS-F203 extension study and 193 patient-years in the MS-F204 extension study.
