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Mixed bag for AstraZeneca drugs

Posted 4 April 2022 AM

The TGA has handed AstraZeneca a win and a loss over the last week approving one new product but also giving the green light to the first generic for big diabetes seller, Forxiga.

Forxiga earned $25.4 million in top-line PBS benefits in the twelve months to December 2021. Cipla Australia has registered the first generic brand of the active, dapagliflozin, under three brand names, Dapaglicip, Focipra and Cipla Dapalgliflozin.

Also under added threat in the diabetes market is MSD's Januvia. It earned $24 million in top-line benefits last year and has a clutch of potential PBS generics eyeing off its revenue to which Apotex has now added two additional brands in a range of doses.

AZ has also succeeded in registering new lupus treatment Saphnelo which has been approved for use in patients with moderate to severe, active systemic lupus erythematosus, despite standard therapy. The regulator noted that the safety and efficacy of Saphnelo have not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus.

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