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FDA approves Circassia's COPD treatment, AZ gets $20M milestone

April 5, 2019 4:12 PM UTC

Circassia said FDA approved Duaklir Pressair aclidinium bromide/formoterol fumarate to treat chronic obstructive pulmonary disease. The agency also accepted for review an sNDA for Tudorza Pressair aclidinium bromide to include on its label clinical data demonstrating a reduction in COPD exacerbations and CV safety.

Circassia Pharmaceuticals plc (LSE:CIR) has full U.S. rights to both products from AstraZeneca plc (LSE:AZN; NYSE:AZN), which will receive a $20 million milestone triggered by Duaklir's approval. Under the terms of the deal, Circassia will also pay AZ $100 million by June 30 (see “AZ, Circassia Deal”)...

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