Updates for: Bovie Medical Corporation (AMEX:BVX), and Acorda Therapeutics (NASDAQ:ACOR)
The following is a list of companies which includes the company name, ticker symbol, decision date, and the lastest updated description and notes. Each entry includes a summary of the pending regulatory or clinical trial catalyst event and other relevant information such as FDA Advisory Panel Meetings or previous decisions, if applicable.
- Pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, and sBLA filings),
- Pending complete response letter (CRL) re-submissions to the FDA,
- Pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval,
- Pending mid and early-stage clinical trial results for small / micro-cap companies.
Bovie Medical Corporation
(AMEX:BVX)
On 7/22/09, BVX (AMEX:BVX) announced a 510(k) submission to the FDA seeking pre-market clearance for the Company’s Polarian Seal-N-Cut vessel sealing line of hybrid monopolar and bipolar forceps. The new Seal-N-Cut line of instruments provides for monopolar and bipolar energy combined with intelligent feedback from Bovie’s Hybrid VS electrosurgical generator. The Seal-N-Cut devices also accommodate a wide array of possible applications in either monopolar or bipolar surgeries thereby serving endoscopic needs in multiple endoscopic fields including Endo GYN, General Surgery, Pediatric surgery, Thoracic Endoscopy and Urology. Bipolar vessel sealing and coagulation is one of the fastest growing markets in Endoscopy, estimated to exceed $1 billion in revenues worldwide. The 1/22/10 date for this entry is a 6-month estimate for a possible FDA response since the Agency does not issue decision date deadlines for medical device submissions.
Acorda Therapeutics Inc.
(NASDAQ:ACOR)
On 4/23/09, ACOR (NASDAQ:ACOR) announced the resubmission of its NDA for Fampridine-SR (Amaya) to the FDA as a new therapy being developed to improve walking ability in people with multiple sclerosis (MS) in response to a Refuse to File letter for the NDA on 3/30/09. On 5/6/09, the FDA accepted the NDA with a priority review (six-month review) designation and a PDUFA action date of 10/22/09 as there are currently no FDA approved treatments to improve the walking ability of people with MS. On 10/14/09, the FDA Peripheral and Central Nervous System Drugs 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 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. On 10/22/09, Acorda announced a three-month extension to its pending PDUFA action date until 1/22/10 following the recent FDA Advisory Panel meeting and additional information that was submitted to the FDA for a REMS program that was accepted by the Agency as a solicited major amendment to the Fampridine-SR NDA.
Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced that the 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
Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010
HAWTHORNE, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that the 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.
“The REMS program is important to ensuring appropriate use of Fampridine-SR, if approved, and we are pleased that the FDA has accepted our amendment,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “We look forward to continuing to work with the FDA as it completes its review of the Fampridine-SR NDA.”
Fampridine-SR is a sustained-release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). In laboratory studies, fampridine has been found to improve impulse conduction in nerve fibers in which the insulating layer, called myelin, has been damaged. Fampridine-SR is being developed by Acorda Therapeutics in the United States and manufactured by Elan Corporation plc.
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