AstraZeneca and Amgen announced that the US Food and Drug Administration (FDA) has approved Tezspire (tezepelumab) for self-administration in a pre-filled, disposable pen for patients with severe asthma, aged 12 years and above.

Tezspire is a human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that plays a vital role in multiple inflammatory cascades.

It is being jointly developed by AstraZeneca and Amgen and is the only biologic approved for severe asthma with no phenotype or biomarker limitation.

Tezspire will be offered as a fixed-dose 210mg subcutaneous injection administered every four weeks, using a pre-filled, single-use auto-injector or a pre-filled, single-use syringe.

The pre-filled pen is equipped with a safety guard, and viewing window, and makes an audible click sound at the start and end of the injection to guide patients.

AstraZeneca biopharmaceuticals business unit executive vice president and president Ruud Dobber said: “Tezspire is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label.

“With the approval of the pre-filled pen in the US, we can now offer greater flexibility to patients and physicians with the option to administer Tezspire at home or in the clinic.”

The FDA approval was supported by results from the PATHFINDER clinical trial programme, which included results from the Phase 1 PATH-BRIDGE and Phase 3 PATH-HOME trials.

In the PATH-HOME clinical trial, 92% of healthcare providers, patients and caregivers successfully administered Tezspire in the clinic and at home throughout the study.

The study also showed that the improvement in asthma control and the safety profile of Tezspire were consistent with previous clinical trials of the drug.

In the PATH-BRIDGE study, pharmacokinetic exposure of Tezspire was comparable with subcutaneous administration via vial-and-syringe (V-S), pre-filled syringe, or AI device.

Tezspire self-administration and the Tezspire pre-filled pen are also approved in the European Union (EU) and are under regulatory review in several other countries worldwide.