AstraZeneca announced that the US Food and Drug Administration has approved the self-administration of asthma drug Fasenra in a pre-filled, single-use auto-injector.
The approval was supported by data from recent trials.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D, said: “Fasenra is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period. Today’s news means we can now offer Fasenra in an even more convenient way, giving US healthcare providers and patients the option of administering Fasenra at home or in a doctor’s office, and making treatment more accessible to patients with severe eosinophilic asthma.”
Fasenra self-administration and the Fasenra Pen are also approved in the European Union.
Reuters reported earlier the original cost of the drug is $38,000 the first year, dropping to $28,000 to $33,000 in future years. The figure is lower than charges for other drugs in that space. Actual costs vary with AstraZeneca offering patient assistance plans and other services offering discounts for people without coverage.
The US approval of the Fasenra Pen provides healthcare professionals and patients the option for Fasenra to be administered outside of a clinical setting via auto-injector by a patient or caregiver after their healthcare professional decides it is appropriate. The Fasenra pre-filled syringe is available for administration by a healthcare professional.
The 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. Fasenra is also in development for other respiratory conditions.
Fasenra was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Kirin Co., Ltd., Japan.
AstraZeneca employs 1,500 in northern Delaware.