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Adalvo announces successful Pivotal BE program for Dapagliflozin

Business
03 February 2023

We are pleased to announce that we have now completed our Pivotal BE program for Dapagliflozin 10mg film-coated tablets. This product has been developed in collaboration with one of our strategic partners.

Our product has been developed based on the reference brand Forxiga 10mg film-coated tablets, which is indicated in the treatment of type 2 diabetes, heart failure and chronic (long-term) kidney disease.

The brand sold approximately $5bn globally in 2021, having a significant growth potential with Global 3Y CAGR at +44%, according to IQVIA.

Based on our positive progress, we believe that we will be ready for launch on Day-1. This development further showcases our ability to bring differentiated products to our partners.

Adalvo is able to offer a number of dossiers within this domain, as depicted below.