LONDON (dpa-AFX) - AstraZeneca (AZN.L, AZN) said the CHMP, European Medicines Agency's Committee, has adopted a positive opinion to add a self-administration option for Fasenra and a new delivery method as a pre-filled, single-use auto-injector (the Fasenra pen) to the medicine's profile.
Also, AstraZeneca said the CHMP has advised a change to the marketing authorisation for Forxiga in patients with type-2 diabetes to include cardiovascular outcomes data from the Phase III DECLARE-TIMI 58 trial. The inclusion allows more people with type-2 diabetes to be treated from the medicine.
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