(Alliance News) - AstraZeneca PLC on Friday said Tezspire has been approved for self-administration in the EU in a new pre-filled pen, for severe asthma patients aged 12 years and older.

The Cambridge-based pharmaceutical company said Tezspire, whose generic name is tezepelumab, received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use for self-administration in a pre-filled, single-use pen.

"The CHMP opinion can be implemented without the need for a European Commission decision due to the nature of the Type-II label variation," Astra said.

The approval was based on results from the Pathfinder clinical trial programme. "The improvements in asthma control and the safety profile of Tezspire observed in the Path-home trial were consistent with previous clinical trials," the company says.

Executive Vice President Mene Pangalos of AstraZeneca 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."

AstraZeneca said it expects a regulatory decision by the US Food & Drug Administration on self-administration and the new pre-filled pen in the first half of 2023.

Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and other countries.

Shares were up 1.7% at 11,642.00 pence each on Friday morning in London.

By Xindi Wei, Alliance News reporter

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