The US Food and Drug Administration (FDA) today approved tezepelumab-ekko (TEZSPIRE®) for self-administration in a pre-filled, single-use pen for patients aged ≥12 years who have severe asthma.
Tezepelumab was approved by the FDA in December 2021 and is the only biologic agent approved for treatment of severe asthma that includes no limitations for either phenotype or biomarker in the approved label, according to a statement from codevelopers Amgen and AstraZeneca.
Today’s approval offers patients with severe asthma the choice to self-administer tezepelumab at home or to continue to receive the injection in a clinical setting.
“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,” said Kenneth Mendez, president and chief executive officer of the Asthma and Allergy Foundation of America in a statement. “We believe self-administration alternatives can play an important role in patients’ lives and address unmet needs for those living with severe asthma.”
The FDA’s decision was based on data from the PATHFINDER clinical trial program with tezepelumab and specifically from 2 trials. The single center PATH-BRIDGE phase 1 trial compared the drug’s pharmacokinetics when administered via vial and syringe, a prefilled syringe (PFS), and a prefilled autoinjector (AI) device. The multicenter PATH-HOME phase 3 trial assessed patient, caregiver, and health care provider-reported functionality and performance of a single-use PFS or AI device used in the clinic and home settings.
The PATH-HOME results showed that the majority (92%) of health care providers, patients, and caregivers were able to successfully administer tezepelumab both in the clinic and at home. Importantly the trial showed for the first time that adolescents can use both devices successfully to administer tezepelumab.
The safety profile of tezepelumab and improvements observed in asthma control during the PATH-HOME trial were consistent with findings of previous clinical trials, according to the companies’ statements. The most common adverse reactions of the therapy were pharyngitis, arthralgia, and back pain.
The fixed-dose 210 mg subcutaneous injection will be available in both the PFS and the AI device to be administered every 4 weeks.
Tezepelumab is a first-in-class human monoclonal antibody that inhibits a primary source of inflammation in patients with severe asthma. It targets and blocks thymic stromal lymphopoietin, or TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and initiates an overreactive immune response to allergic, eosinophilic, and other types of airway inflammation associated with severe asthma.
The therapy is indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma in the United States.