Biologic without phenotype or biomarker limitations approved for asthma patients

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AstraZeneca and Amgen’s Tezspire (tezepelumab) has been approved by the FDA 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.

The FDA approval 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. The majority (92%) of health care providers, patients and caregivers were able to successfully administer Tezspire both in the clinic and at home throughout the PATH-HOME trial. The improvements in asthma control and the safety profile of Tezspire observed in the PATH-HOME trial were consistent with previous clinical trials.

“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 health care 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,” Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America.

Tezspire self-administration and the Tezspire pre-filled pen are also approved in the European Union and are under regulatory review in several other countries. 

Clinical trials

PATH-HOME was a phase III multi-centre, open-label, parallel-group trial designed to assess patient, caregiver and health care provider-reported functionality and performance of a single-use, pre-filled syringe  or auto-injector with a fixed 210mg dose of Tezspire administered subcutaneously every four weeks in a clinic and in an at-home setting in 216 patients aged 12 years and older with severe asthma.

The majority (92%) of health care providers, patients and caregivers were able to successfully administer the Tezspire pre-filled pen both in the clinic and at home throughout the trial. At-home administration of the Tezspire pre-filled pen at weeks 12 and 16 was successful in 97% of the patients or caregivers (102/105). The trial also demonstrated for the first time that adolescents can successfully administer Tezspire using the two devices. The very low proportion of device malfunctions (0.9% of PFS and 0.8% of AIs) provides support that the instructions for use provided to health care providers, patients and caregivers is adequate for successful subcutaneous administration of Tezspire both in the clinic and at home.

PATH-BRIDGE was a single-center, randomized, open-label, parallel-group phase I trial in healthy people to compare the pharmacokinetic exposure following a single 210mg dose of Tezspire by using a vial-and-syringe, PFS or pre-filled AI device. Tezspire PK exposure was comparable following subcutaneous administration via V-S, PFS or AI. In addition, injection site-pain was low in severity and injection-site reactions were uncommon in all device groups.

In addition to PATH-BRIDGE and PATH-HOME, the Pathfinder clinical trial program included the pivotal Navigator phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.7


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