Kyndrisa Approval Status
FDA Approved: No
Brand name: Kyndrisa
Generic name: drisapersen
Company: BioMarin Pharmaceutical Inc.
Treatment for: Duchenne Muscular Dystrophy
Kyndrisa (drisapersen) is an investigational antisense oligonucleotide in development for the treatment of Duchenne muscular dystrophy amenable to exon 51 skipping.In January 2016, BioMarin Pharmaceutical Inc. announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) advising the company that the New Drug Application for Kyndrisa was not ready for approval in its present form. The FDA concluded that the standard of substantial evidence of effectiveness had not been met. BioMarin will review the Complete Response Letter and work with the FDA to determine the appropriate steps regarding future of the application.
Development Status and FDA Approval Process for Kyndrisa
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