(Alliance News) - AstraZeneca PLC on Monday said it has received positive opinions in the EU for drugs Forixga and Fasenra.
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended changing Forixga's EU marketing authorisation in type-2 diabetics to include cardiovascular outcomes data from the drug maker's phase 2 Declare-TIMI 58 trial.
The trial showed Forixga produced a statistically significant drop in hospitalisation for heart failure of cardiovascular death compared to a placebo. Moreover, patients taking Forixga also had a lower chance of major adverse cardiovascular events - though not at a statistically significant level.
"We are pleased with this positive opinion for the cardiovascular outcomes and renal data for Forxiga and this recommendation acknowledges that even more people with type-2 diabetes could benefit from this medicine," said Mene Pangalos, executive vice president of BioPharmaceuticals Research & Development at Astra.
Separately, FTSE 100 drug maker Astra said the CHMP also gave a positive opinion on adding a self-administration option to asthma drug Fasenra and a new delivery method of a "pre-filled, single-use auto-injector" - known as the Fasenra pen - to product information in the EU.
Fasenra treats severe, eosinophilic asthma - a type of asthma where patients produce too many white blood cells called eosinophils, which cause inflammation of the lungs.
Astra said the committee's opinion can be put in place without requiring a decision from the European Commission because of the type of label variation.
Pangolas also commented on the Fasenra opinion, saying: "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. We hope self-administration and the Fasenra pen will play important roles in helping physicians make treatment with biologic medicines accessible to more people with severe eosinophilic asthma."
Shares in Astra were up 0.4% at 6,466.00 pence on Monday morning.
Astrazeneca (AZN)
