AstraZeneca’s Tezspire gains CHMP approval for the treatment of severe asthma

AstraZeneca has announced that Tezspire (also known as tezepelumab) has received approval from the EMA’s Committee for Medicinal Products for Human Use (CHMP) in the EU to treat patients over the age of 12 with severe asthma.

The drug is approved for self-administration in severe asthma patients, and takes the form of a single-use, pre-filled pen.

Tezspire has already received approval in Japan, the EU, the US and various other countries. Developed in partnership with Amgen, the drug is a first-in-class monoclonal antibody which inhibits TSLP action.

According to AstraZeneca, the treatment does not require a European Commission (EC) decision due to the nature of the variation in the Type-II label.

The CHMP’s decision follows results from the PATHFINDER clinical trial programme, including data from the phase 1 PATH-BRIDGE trial and the phase 3 PATH-HOME trial, during which 92% of patients, healthcare providers and caregivers were able to efficiently administer Tezspire both at home and in the clinic. The PATH-HOME trial also showed that Tezspire improved asthma control and had a consistent safety profile.

Mene Pangalos, AstraZeneca BioPharmaceuticals research and development executive vice-president, commented: “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.”

Betsy Goodfellow