FDA Approves Pre-Filled Pen for Self-Administration of Tezepelumab-ekko to Treat Asthma

The FDA has approved tezepelumab-ekko (Tezspire, Amgen and AstraZeneca) for self-administration with a new pre-filled, single-use pen for patients aged 12 years and older with severe asthma.¹

Tezepelumab-ekko was first approved in December 2021 and is the only biologic approved for severe asthma with no phenotype or biomarker limitation within its approved label.¹ It is a first-in-class human monoclonal antibody that works on the airway epithelium, which is the primary source of inflammation and the first point of contact for viruses, allergens, pollutants, and other environmental insults.¹

Specifically, tezepelumab-ekko targets and blocks TSLP, an epithelial cytokine that sits at the top of multiple inflammatory cascades and initiatives an overreactive immune response to allergic, eosinophilic, and other types of airway inflammation associated with severe asthma. Expression of TSLP is increased in the airways of patients with asthma and has been correlated with disease severity.¹

Data used in the original approval for tezepelumab-ekko showed consistent efficacy with a 71% (≥300 cells per microliter), 48% (<300 cells per microliter), and 48% (<150 cells per microliter) reduction in the annualized asthma exacerbation rate (AAER) over 52 weeks, compared to treatment with placebo and standard of care.²

Additionally, in a pre-specified exploratory analysis from the NAVIGATOR trial, tezepelumab-ekko demonstrated consistent efficacy regardless of the season. According to trial results, AAER was reduced by 63% in the winter, 46% in the spring, 62% in the summer, and 54% in the fall compared to placebo. Across all seasons, the proportion of patients with an exacerbation was lower in the tezepelumab-ekko group than in the placebo group.²

The new approval is based on results from the PATHFINDER clinical trial program, including results from the PATH-BRIDGE phase 1 trial and the PATH-HOME phase 3 trial.¹

“People with severe asthma will now have the flexibility to administer Tezspire at home or continue to receive their medicine in their doctor’s office,” said Murdo Gordon, executive vice president of global commercial operations at Amgen, in a press release. “This approval reinforces our continued efforts to improve accessibility to Tezspire, a first-in-class medicine proven to consistently and significantly reduce exacerbations across a broad population of people with severe asthma.”¹

In the PATHFINDER clinical trial program, 92% of health care providers, patients, and caregivers were able to successfully administer tezepelumab-ekko both in the clinic and at home in the PATH-HOME trial. The improvements in asthma control and the safety profile of tezepelumab-ekko observed in the PATH-HOME trial were consistent with previous clinical trials.¹

The most common adverse events with tezepelumab-ekko are pharyngitis, arthralgia, and back pain. Self-administration with the tezepelumab-ekko pre-filled pen is also approved in the European Union and is under regulatory review in several other countries around the world.¹

“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,” said Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America, in the 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.”¹

REFERENCES

1. Tezspire approved for self-administration in the US with a new pre-filled pen. News release. Amgen; February 2, 2023. Accessed February 6, 2023. https://www.amgen.com/newsroom/press-releases/2023/02/tezspire-approved-for-self-administration-in-the-u-s--with-a-new-pre-filled-pen
2. Antrim A. Data analysis shows promise for tezepelumab-ekko in patients with severe asthma. Pharmacy Times. March 4, 2022. Accessed February 6, 2023. https://www.pharmacytimes.com/view/data-analysis-shows-promise-for-tezepelumab-ekko-in-patients-with-severe-asthma