Kyndrisa
Generic name: drisapersen
Treatment for: Duchenne Muscular Dystrophy
BioMarin Announces That FDA Has Advised it Will Not Take Action on the Kyndrisa (drisapersen) NDA by the PDUFA Date
SAN RAFAEL, Calif., Dec. 18, 2015 (GLOBE NEWSWIRE) -- BioMarin Pharmaceutical Inc. (Nasdaq:BMRN) announced today that the U.S. Food and Drug Administration (FDA) has notified the Company that they had not yet completed their review process and would be unable to take an action by the Prescription Drug User Fee Act (PDUFA) action date for Kyndrisa (drisapersen) of December 27, 2015, and anticipate taking action in early January 2016.
About BioMarin
BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare and ultra-rare genetic diseases. The company's portfolio consists of five commercialized products and multiple clinical and pre-clinical product candidates. For additional information, please visit www.BMRN.com.
Forward-Looking Statement
This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: expectations regarding the FDA's review of the Kyndrisa NDA, outcomes of the review of such filings; and the possible approval of Kyndrisa. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. These risks and uncertainties include, among others: results and timing of current and planned clinical trials of Kyndrisa; the content and timing of decisions by the FDA, and EMA concerning Kyndrisa; and those factors detailed in BioMarin's filings with the Securities and Exchange Commission, including, without limitation, the factors contained under the caption "Risk Factors" in BioMarin's 2014 Annual Report on Form 10-K, as amended, and the factors contained in BioMarin's reports on Form 8-K. Stockholders are urged not to place undue reliance on forward-looking statements, which speak only as of the date hereof. BioMarin is under no obligation, and expressly disclaims any obligation to update or alter any forward-looking statement, whether as a result of new information, future events or otherwise. Kyndrisa™ is our trademark, and BioMarin® is a registered trademark of BioMarin Pharmaceutical Inc.
Source: BioMarin Pharmaceutical Inc.
Posted: December 2015
Related articles
- FDA Issues Complete Response Letter for Kyndrisa for Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping - January 14, 2016
- BioMarin Announces FDA Advisory Committee to Review Drisapersen for Treatment of Patients With Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping - October 15, 2015
- BioMarin Receives Rare Pediatric Disease Designation From FDA for Drisapersen for the Potential Treatment of Duchenne Muscular Dystrophy - August 19, 2015
- BioMarin Announces FDA Accepts Drisapersen NDA for Treatment of Duchenne Muscular Dystrophy Amenable to Exon 51 Skipping - June 29, 2015
- BioMarin Completes Rolling NDA Submission to FDA for Drisapersen for Duchenne Muscular Dystrophy - April 27, 2015
- Prosensa Begins NDA Submission for Drisapersen to treat Duchenne Muscular Dystrophy - October 10, 2014
- Prosensa Announces Regulatory Path Forward for Drisapersen as a Potential Treatment for DMD - June 3, 2014
Kyndrisa (drisapersen) FDA Approval History
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