Tezspire is a human monoclonal antibody that inhibits the action of TSLP, an important epithelial cytokine responsible for multiple inflammatory cascades, and is jointly developed by AstraZeneca and Amgen
AstraZeneca has received a positive opinion from the European Medicine Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for its Tezspire (tezepelumab).
The EU committee recommended Tezspire for self-administration in a pre-filled single-use pen, for use in patients with severe asthma, aged 12 years and above.
The CHMP opinion can be implemented without the need for a European Commission (EC) decision, based on its nature of being Type-II label variation.
Tezspire is a human monoclonal antibody, designed to inhibit the action of TSLP, an important epithelial cytokine responsible for multiple inflammatory cascades.
AstraZeneca developed the drug in collaboration with US-based pharmaceutical company Amgen, which was initiated in 2020, and updated in 2012.
In October last year, Tezspire was granted Orphan Drug Designation by the FDA to treat EoE, and is approved in the US, EU, Japan and other countries to treat severe asthma.
The drug is currently being developed for other indications including COPD, chronic rhinosinusitis, chronic spontaneous urticaria and eosinophilic esophagitis (EoE).
AstraZeneca anticipates a regulatory decision by the US Food and Drug Administration (FDA) on self-administration and the new pre-filled pen in the first half of 2023.
AstraZeneca biopharmaceuticals R&D executive vice president Mene Pangalos said: “Tezspire is the first and only biologic approved in Europe for patients with severe asthma with no phenotype or biomarker limitation.
“With the approval of the Tezspire pre-filled pen, we can give patients in Europe greater flexibility and support physicians in treating a broad population of severe asthma patients.”
The British drugmaker will offer Tezspire as a fixed-dose 210mg subcutaneous injection via a pre-filled, single-use auto-injector or syringe, dubbed the Tezspire pre-filled pen or syringe.
With the Tezspire pre-filled pen, patients and caregivers can easily self-administer the medicine at home or in clinic.
It comes with a safety guard, viewing window and audible clicks feature to guide patients.
The EU approval of Tezspire was based on results from the PATHFINDER clinical trial programme, which includes the Phase 1 PATH-BRIDGE, Phase 3 PATH-HOME, and Phase 3 NAVIGATOR trials.
In a separate development, AstraZeneca has signed a cooperation agreement with China’s Genertec Meheco for Covid-19 antibody drug Evusheld.
Genertec Meheco, a company of China Meheco Group, will import and distribute Evusheld in mainland China, once the drug is approved in the Chinese market.