FDA Approves Tezepelumab for Self-Administration With New Pre-Filled Pen

AstraZeneca and Amgen’s tezepelumab(Tezspire), the first and only respiratory biologic without phenotype or biomarker limitations, has been approved for self-administration in the United States for the treatment of severe asthma in patients aged 12 years or older.

Announced on February 2, the pre-filled, single-use pen can now be administered at home in addition to a doctor’s office for patients ages 12 years and older, offering patients their choice of preferred administration.The approval comes following the results of the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE phase 1 and PATH-HOME phase 3 trials. During the trials, 92% of healthcare providers, patients, and caregivers were able to successfully administer the drug.

“Tezspire is the first and only biologic approved for patients with severe asthma with no phenotype or biomarker limitation within its approved label,” Ruud Dobber, Executive Vice Presidents of the BioPharmaceuticals Business Unit at AstraZeneca said in the statement. “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.”

Tezepelumabwas previously approved by the FDA in 2021 following a Priority Review based on the results from the PATHFINDER clinical trial program. In its pivotal NAVIGATOR phase 3 trial, tezepelumabdemonstrated superiority across all primary and key secondary endpoints in patients with severe asthma when added to standard therapy. Its 2023 approval is specifically for self-administration of the drug.

The tezepelumabpre-filled pen will be available as a fixeddose of 210mg that is to be administered every 4 weeks. The pre-filled pen makes it easier for patients and caregivers to self-administer the medication. Equipped with a safety guard and viewing window, the device has audible clicks at the beginningand end of injection to guide patients.

According to the statement, tezepelumabis being developed as “a first-in-class human monoclonal antibody that inhibits the action of TSLP, a key epithelial cytokine that sits at the top of multiple inflammatory cascades and is critical in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.”

Tezepelumabis indicated for the add-on maintenance treatment of severe asthmas in patients aged 12 years and older. The most common adverse reactions included pharyngitis, arthralgia, and back pain. There is currently no data on tezepelumabuse in pregnant women to test for any drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes

Thetezepelumabpre-filled pen and self-administration are also approved in the European Union and Japan, and it is currently under regulatory review in several other countries.

“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,” Kenneth Mendez, President and CEO of the Asthma and Allergy Foundation of America, said 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.”

Reference

1. TEZPSIRE approved for self-administration in the US with a new pre-filled pen. News Release. AstraZeneca. February 2, 2023. Accessed February 3, 2023. https://www.astrazeneca-us.com/media/press-releases/2023/tezspire_approved_for_self_administration_in_the_us_with_a_new_pre_filled_pen.html

2. FDA approves TEZSPIRE™ (tezepelumab-ekko) in the U.S. for severe asthma. News release. Amgen. Published December 17, 2021. Accessed February 3, 2023.https://www.amgen.com/newsroom/press-releases/2021/12/fda-approves-tezspire-tezepelumabekko-in-the-us-for-severe-asthma