Amgen, AstraZeneca's asthma therapy Tezspire's self-administration option gets FDA approval
Grandbrothers


The U.S. Food and Drug Administration (FDA) approved a self-administration option of Amgen (NASDAQ:AMGN) and AstraZeneca's (NASDAQ:AZN) asthma therapy Tezspire.
The approval is for Tezspire's self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. AstraZeneca said Tezspire (tezepelumab-ekko) is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.

The FDA 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 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," said Ruud Dobber, executive vice president and president, BioPharmaceuticals Business Unit, AstraZeneca.
Tezspire self-administration and the Tezspire pre-filled pen are also approved in the EU, and are under regulatory review in certain other countries, the company added.