FDA Grants Tikvah Therapeutics Orphan Drug Status for Sodium Phenylbutyrate for the Treatment of Spinal Muscular Atrophy

ATLANTA, Aug. 20, 2007 (PRIME NEWSWIRE) -- Tikvah Therapeutics, Inc., a biopharmaceutical company focused on new treatment options to better manage central nervous system diseases, announced today that the U.S. Food and Drug Administration (FDA) has granted Tikvah Therapeutics orphan drug status for sodium phenylbutyrate for the treatment of spinal muscular atrophy (SMA). Orphan drug designation entitles Tikvah to seven years of market exclusivity for phenylbutyrate for the treatment of patients with spinal muscular atrophy. Additional incentives for orphan drug development include tax credits related to certain development expenses, an exemption from the FDA user fee and FDA assistance in clinical trial design.

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