AstraZeneca and Amgen Receive the US FDA’s Approval of Tezspire (tezepelumab) for the Treatment of Severe Asthma


The US FDA has approved Tezspire for self-administration in a pre-filled, single-use pen for patients aged ≥12yrs. with sev. asthma
The approval was based on the (PATHFINDER) program incl. results from the P-I trial (PATH-BRIDGE) & P-III trial (PATH-HOME) evaluating Tezspire (210mg). In the (PATH-HOME) trial, 92% of healthcare providers, patients, and caregivers were able to successfully administer Tezspire in the clinic & home along with an improvement in asthma control & safety profile was consistent with prior trials
Tezspire is also supplied in a single-dose vial or prefilled syringe. The therapy was approved in the US, EU, Japan & other countries and is under regulatory review in multiple other countries globally

Ref: Astrazeneca | Image: Astrazeneca

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