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AstraZeneca

AstraZeneca gets two positive opinions from European Medicines Agency committee

The Committee for Medicinal Products for Human Use (CHMP) recommended that diabetes medicine Forxiga should have its marketing authorisation updated to include cardiovascular data from recent clinical trials

diabetes
The committee also issued a positive opinion to add a self-administration option for Fasenra asthma drug via a pre-filled, single-use auto-injector ‘pen’

Two AstraZeneca PLC (LON:AZN) drugs have received positive opinions from the European Medicines Agency's advisory committee.

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.

READ: AstraZeneca first-quarter profits double as product sales revival continues but cash still a worry

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.

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Market Cap: £95.19 billion
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