THOUSAND OAKS (dpa-AFX) - 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.
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