AstraZeneca’s Tezspire (tezepelumab) Receives the EU Approval for the Treatment of Severe Asthma
- The EMA’s CHMP issued a positive opinion on Tezspire (tezepelumab) 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
- The US FDA’s decision on self-administration and the new pre-filled pen is expected in H1’23. The therapy was approved in the US, EU, Japan & other countries for the treatment of sev. asthma
Ref: AstraZeneca | Image: AstraZeneca
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