AZ Sees A Future For Forxiga In Type 1 Diabetes
The EMA is looking at a marketing authorization variation for the type 2 diabetes blockbuster SGLT-2 inhibitor for use as an oral adjunct treatment to insulin in adults with type 1. Observers will be interested to see what stance the agency takes on the slightly higher number of diabetic ketoacidosis events seen in trials supporting the submission.
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Forxiga is the first oral medicine approved in the EU as an adjunct to insulin for type 1 diabetes and the regulatory boost for AstraZeneca comes as Sanofi gets a CRL from the FDA for Zynquista.
Several major products have been recommended for wider indications in the EU, including Roche’s hemophilia drug Hemlibra, Sanofi’s Praluent in atherosclerotic disease, and AstraZeneca’s Forxiga for type 1 diabetes.
Seven new drug applications got the thumbs up this week from the EMA's drug evaluation committee, the CHMP. Their EU approval should now be a formality. Two new Shionogi treatments are set for approval, as are two orphan products – one from Medac, the other from AOP Orphan Pharmaceuticals. Pfizer got the OK for one biosimilar but has withdrawn an application for another.