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Adalvo Announces Successful Pivotal BE Outcome For Apixaban 5mg Film Coated Tablets

22 February 2022

Adalvo is delighted to announce that we have successfully completed our Pivotal BE study of Apixaban 5mg Film Coated Tablets.

Our product has been developed based on the reference brand Eliquis which is indicated for the treatment of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) and sold at around $17.3bn in 2020, according to IQVIA.

We are now moving ahead into dossier completion which is expected in Q2 2022 and will proceed with DCP submission, which is scheduled for early Q3 2022.

Based on our positive progress and robust supply chain we expect to be amongst the first-to-market companies in all our major markets, with a very competitive cost structure.