FDA Approves Tezspire in Pre-Filled Pen

The FDA has approved Tezspire (tezepelumab-ekko) in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. First approved by the FDA in December 2021, Tezspire is a first-in-class biologic for severe asthma. It targets thymic stromal lymphopoietin (TSLP), which plays a role in the inflammation associated with asthma.

Developed by Amgen and AstraZeneca, the original Tezspire delivered via a single-use syringe has a list price of $3,847.35 per 210 mg/mL, which is given every four weeks. A spokesperson for the companies indicated that the pricing of the pre-filled will be made available when it launches.

The spokesperson said the Tezspire Together Fast Start program helps eligible commercially insured patients start therapy quickly should they face a delay in coverage. Eligible patients may receive up to 12 no-cost doses and may start therapy before the Prior Authorization is submitted. Once coverage is secured, the Tezspire Together Co-pay program can help eligible commercially insured patients reduce their out-of-pocket costs for medication and in-office administration. Patients pay as little as $0 per dose and there are no income restrictions.

Kenneth Mendez

“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 chief executive officer of the Asthma and Allergy Foundation of America, said in a press release. “We believe self-administration alternatives can play an important role in patients' lives and address unmet needs for those living with severe asthma.”

The approval was based on results from the PATHFINDER clinical trial program, which included results from the PATH-BRIDGE phase 1 trial and the PATH-HOME trial phase 3 trial. The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer Tezspire both in the clinic and at home. The improvements in asthma control and the safety profile observed in the PATH-HOME trial were consistent with previous clinical trials. The most common adverse reactions were pharyngitis, arthralgia, and back pain.