Eagle Pharmaceuticals Inc. said Monday that AOP Orphan Pharmaceuticals GmbH, a member of AOP Health, has begun discussions with the U.S. Food and Drug Administration to obtain alignment on the content and format of the pre-clinical and clinical data required to support a new drug application seeking approval of Landiolol.
Landiolol is a novel therapeutic for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
In August 2021, Eagle entered into a licensing agreement with AOP Health, a privately owned Austrian company devoted to the treatment of rare and special diseases, for the commercial rights to Landiolol in the U.S.
Eagle said Landiolol has never been marketed in the U.S., and it expects five years of new chemical entity exclusivity upon approval. Based on the FDA's responses to AOP Health's communications, the company remains on track to support the NDA next quarter.
Landiolol is already commercially available in Japan and several European markets.
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