AstraZeneca announced 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 severe form of asthma.
The positive opinion for self-administration and the Fasenra pen is supported by the Phase III trials.
Mene Pangalos, executive vce president, BioPharmaceuticals R&D, said: “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.”
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.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries.
The new Fasenra pen 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.
Fasenra is 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. Fasenra is also in development for other conditions.
Fasenra was developed by AstraZeneca, which employs 1,500 in Delaware.