AstraZeneca's Tezspire approved for self-administration in US
The US Food and Drug Administration (FDA) has approved AstraZeneca and Amgen's Tezspire for self-administration using a new pre-filled pen for severe asthma patients aged 12 and older.
AstraZeneca and Amgen announced that the US Food and Drug Administration (FDA) has approved Tezspire (tezepelumab) for self-administration via a pre-filled, single-use pen. This approval is for patients aged 12 years and older suffering from severe asthma.
Tezspire is a biologic therapy approved for severe asthma without limitations based on phenotype or biomarker. The new approval offers patients the flexibility to administer the medication at home or in a doctor's office.
The FDA's decision was informed by data from the PATHFINDER clinical trial program, including the PATH-BRIDGE Phase I and PATH-HOME Phase III trials. In the PATH-HOME study, 92% of healthcare providers, patients, and caregivers successfully administered Tezspire in both clinical and home settings. The study demonstrated consistent efficacy and safety compared to prior trials.
Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, stated that the Tezspire pre-filled pen provides increased choice and flexibility for patients and healthcare providers managing severe asthma, addressing unmet needs for self-administration options.
The Tezspire pre-filled pen is already approved and available in the European Union and is under review in several other countries. Tezspire is currently approved for severe asthma treatment in Japan and other nations.