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Arena Pharmaceuticals’ Drug Candidate Granted Orphan Status From FDA

Arena Pharmaceuticals Inc. announced that the Food and Drug Administration has granted orphan drug status to the company’s drug candidate for the treatment of pulmonary arterial hypertension.

“We are pleased with the designation of orphan drug status for the active moiety of APD811, and we look forward to advancing this drug candidate into a Phase 2 clinical trial program later this year,” said Craig Audet, Arena’s senior vice president of pperations and head of global regulatory affairs.

The FDA Office of Orphan Products Development evaluates scientific and clinical data submissions from sponsors to identify and designate drug candidates that could potentially treat rare diseases to help advance the evaluation and development of such products. Orphan drug designation qualifies the sponsor of the drug candidate for various development incentives. Orphan drug status applies specifically to the active moiety and the indication for which it is granted, and is not applicable to other indications for that moiety.

APD811 is an investigational drug candidate internally discovered and developed by Arena (NASDAQ: ARNA) and intended for the treatment of vasospastic diseases.

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