The Committee for Medicinal Products for Human Use (CHMP) recommended that diabetes medicine Forxiga should have its marketing authorisation updated to include cardiovascular outcomes data from recent clinical trials.
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Mene Pangalos, the FTSE 100 group’s biopharma research chief, said the recommendation "acknowledges that even more people with type-2 diabetes could benefit from this medicine".
The CHMP also issued a positive opinion to add an option for patients to self-administer Astra’s Fasenra asthma drug via a new delivery method as a pre-filled, single-use auto-injector ‘pen’.
This change can be implemented without the need for a European Commission decision due to the nature of the Type-II label variation, the company noted.
US regulatory permission on self-administration and the new pre-filled, single-use auto-injector device is anticipated for the second half of 2019
"Fasenra is the only respiratory biologic medicine that can be administered every eight weeks after the initial loading-dose period, and this positive opinion means we are closer to offering Fasenra in a way that is even more convenient for many patients,” said Pangalos.
AstraZeneca shares were up 0.5% to 6,471p on Monday morning.