Sandoz gets USFDA nod for Enzeevu
Basel: Sandoz has announced that the US Food and Drug Administration (FDA) has approved Enzeevu (aflibercept-abzv) 2 mg vial kit and pre-filled syringe for intravitreal injection.
Enzeevu is indicated to improve and maintain visual acuity in patients with neovascular age-related macular degeneration (nAMD). In addition, the FDA provisionally determined Enzeevu would be interchangeable with the reference medicine as it is currently subject to an unexpired exclusivity for the first interchangeable biosimilar products.
Claire D’Abreu-Hayling, Chief Scientific Officer, Sandoz, said, “nAMD, or wet AMD, continues to be a leading cause of vision impairment in patients over 50 years in North America. This condition affects millions of people, leading to significant challenges in their daily lives due to the progressive loss of central vision. The US approval of Enzeevu is a key milestone in Sandoz efforts to significantly improve the lives of patients impacted by this incurable disease.”
Read also: Sandoz unveils biosimilar Pyzchiva across Europe to treat chronic inflammatory diseases
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