AstraZenecaannounced that the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion to add a self-administered pre-filled, single-use pen to the medicine’s product information in the European Union.
The pen will administer Fasenra, a drug used to treat a severeform of asthma.
The positive opinion for self-administration and theFasenrapen is supported by the Phase III trials.
Mene Pangalos, executive vce president, BioPharmaceuticals R&D, said: “Fasenrais 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 offeringFasenrain a way that is even more convenient for many patients.We hope self-administration and theFasenrapen will play important roles in helping physicians make treatment with biologic medicines accessible to more people with severe eosinophilic asthma.”
AstraZeneca anticipates a regulatory decision by the US Food and Drug Administration (FDA) on self-administration and the new pre-filled, single-use auto-injector device in the second half of this year.
Fasenrais currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries.
The newFasenrapen enables patients and caregivers to administer the medicine via a simple two-step process. The device includes a viewing window and audible clicks at the start and end of the injection to guide patients with successful administration.
Fasenrais AstraZeneca’s first respiratory biologic, now approved as an add-on maintenance treatment in severe, eosinophilic asthma in the US, EU, Japan and several other countries, with further regulatory reviews ongoing.Fasenrais also in development for other conditions.
Fasenrawas developed by AstraZeneca, which employs 1,500 in Delaware.