AstraZeneca, Amgen's Tezspire Pre-filled Pen Receives FDA Approval In US For Asthma

(RTTNews) - AstraZeneca Plc (AZN) and Amgen Inc (AMGN)'s Tezspire got FDA approval in the US, based on the pathfinder clinical trial program.

The approval is for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan, and other countries.4-6

AstraZeneca said 92 percent of healthcare providers, patients and caregivers were able to successfully administer Tezspire in the clinic and at home throughout the PATH-HOME trial.

Earlier Tezspire self-administration and the pre-filled pen got approval in the European Union.