UCBJY - UCB's therapy gets FDA orphan drug status to treat seizures linked with rare epilepsy

The U.S. Food and Drug Administration granted orphan drug designation to UCB's (OTCPK:UCBJY) (OTCPK:UCBJF) fenfluramine hydrochloride to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder. CDKL5 deficiency disorder is a rare developmental epileptic encephalopathy (DEE) caused by mutations in the CDKL5 gene. DEE are a group of epilepsies which are characterized by seizures and encephalopathy (progressive dysfunction of brain). Belgium-based UCB inherited fenfluramine hydrochloride via the acquisition of Zogenix, which was completed in March. The FDA grants orphan drug status to therapies which are aimed at treating a rare disease or condition which affects less than 200K people in the U.S. The designation also carries certain incentives, including seven years of market exclusivity if the drug is approved.

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UCB's therapy gets FDA orphan drug status to treat seizures linked with rare epilepsy