Amgen, AstraZeneca's asthma therapy Tezspire's self-administration option gets approval in EU
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A panel of the European Medicine Agency (EMA) issued a positive opinion on a self-administration option of Amgen (NASDAQ:AMGN) and AstraZeneca's (NASDAQ:AZN) asthma therapy Tezspire.
The decision of the EMA's Committee for Medicinal Products for Human Use (CHMP) can be implemented without the need for a European Commission (EC) decision due to the nature of the Type-2 label variation, AstraZeneca said in a press release on Friday.
The approval for Tezspire (tezepelumab) was for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.
The British pharma giant noted that Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.
The CHMP decision was backed by data from the PATHFINDER clinical trial program, which included results from a phase 1 trial called PATH-BRIDGE and a phase 3 study, dubbed PATH-HOME.
"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," said Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca.
The company expects a regulatory decision by the U.S Food and Drug Administration (FDA) on self-administration and the new pre-filled pen in H1 2023.
Tezspire is currently approved to treat severe asthma in the U.S., EU, Japan and certain other countries.