AstraZeneca wins EMA backing for Fasenra and Forxiga changes
AstraZeneca on Monday received positive opinions on changes to the delivery and marketing of two of its products from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
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The committee has backed a self-administration option for Fasenra, allowing the eosinophilic asthma treatment's product information to detail a new delivery method as a pre-filled, single-use auto-injector, in a measure that can be implemented throughout the European Union without the need for a European Commission decision.
The FTSE 100-listed company said it also anticipates a regulatory decision by the US Food and Drug Administration on self-administration and a new pre-filled, single-use auto-injector device in the second half of 2019.
Meanwhile, the CHMP also threw its weight behind a marketing change for type-2 diabetes drug Forxiga, allowing the company to include cardiovascular outcomes data from the Phase III DECLARE-TIMI 58 trial, in which the medicine achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure or cardiovascular death versus placebo.
The biopharmaceutical company added that further regulatory reviews and submissions regarding the treatment are ongoing in several countries, including the US, China and Japan.