TEZSPIRE approved for self-administration in the US with a new pre-filled pen
AstraZeneca and Amgen’s TEZSPIRE (tezepelumab-ekko) has been approved in the US for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. TEZSPIRE is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.1
The approval by the US Food and Drug Administration (FDA) was based on results from the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trial.2,3 The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer TEZSPIRE both in the clinic and at home throughout the PATH-HOME trial.3 The improvements in asthma control and the safety profile of TEZSPIRE observed in the PATH-HOME trial were consistent with previous clinical trials.3
Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, said: “Severe asthma continues to be a very complex condition to manage, so we welcome the TEZSPIRE pre-filled pen as an option that will empower patients and healthcare providers with increased choice. We believe self-administration alternatives can play an important role in patients’ lives and address unmet needs for those living with severe asthma.”
Ruud Dobber, Executive Vice President and President, BioPharmaceuticals Business Unit, AstraZeneca, said: “TEZSPIRE is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label. 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.”
TEZSPIRE self-administration and the TEZSPIRE pre-filled pen are also approved in the European Union (EU) and are under regulatory review in several other countries around the world. TEZSPIRE is currently approved for the treatment of severe asthma in the US, EU, Japan and other countries.4-6
TEZSPIRE (tezepelumab-ekko) Important Safety Information
CONTRAINDICATIONS
Known hypersensitivity to tezepelumab-ekko or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions
Hypersensitivity reactions were observed in the clinical trials (eg, rash and allergic conjunctivitis) following the administration of TEZSPIRE. Postmarketing cases of anaphylaxis have been reported. These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). In the event of a hypersensitivity reaction, consider the benefits and risks for the individual patient to determine whether to continue or discontinue treatment with TEZSPIRE.
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