The US Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca’s Tezspire (tezepelumab-ekko) for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above.
Being jointly developed by AstraZeneca and Amgen, Tezspire is a first-in-class human monoclonal antibody and inhibits TSLP, an important epithelial cytokine that plays a vital role in multiple inflammatory cascades.
It was initially FDA-approved in December 2021 and is claimed to be the only biologic approved to treat severe asthma with no phenotype or biomarker limitation.
Tezspire will be given as a fixed-dose 210mg subcutaneous injection every four weeks, using a single-use, pre-filled auto-injector or through a pre-filled, single-use syringe.
Amgen Global Commercial Operations executive vice-president Murdo Gordon said: “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.
“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.”
The regulatory approval was based on the results obtained from the PATHFINDER clinical trial programme that included data from the Phase I PATH-BRIDGE and the Phase III PATH-HOME trials.
In the PATH-HOME trial, 92% of healthcare providers, patients and caregivers successfully administered Tezspire in the clinic and at home throughout the study.
Asthma control improvement and safety profile were consistent with previous clinical trials.
Pharyngitis, arthralgia, and back pain are the most common adverse reactions of the antibody.
The antibody has already been approved for the same indication in Japan, the EU, the US and other countries.