Amgen, AstraZeneca obtain FDA nod for Tezspire self-administration

Amgen and AstraZeneca have obtained the Food and Drug Administration’s blessing for Tezspire (tezepelumab-ekko) for self-administration in a pre-filled, single-use pen for patients aged 12 years old and older with severe asthma.

First approved by the FDA in December 2021, Tezspire is the only biologic approved for severe asthma with no phenotype (e.g., eosinophilic or allergic) or biomarker limitation within its approved label.

"People with severe asthma will now have the flexibility to administer Tezspire at home or continue to receive their medicine in their doctor's office," said Murdo Gordon, executive vice president of global commercial operations at Amgen. "This approval reinforces our continued efforts to improve accessibility to Tezspire, a first-in-class medicine proven to consistently and significantly reduce exacerbations across a broad population of people with severe asthma."

[Read more: FDA gives AstraZeneca approval for Imfinzi]

"Severe asthma continues to be a very complex condition to manage, so we welcome the Tezspire pre-filled pen as an option that will empower patients and healthcare providers with increased choice," said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America. "We believe self-administration alternatives can play an important role in patients' lives and address unmet needs for those living with severe asthma."