FDA grants breakthrough designation to Amgen and AstraZeneca’s Tezspire
In its financial report for the second quarter of 2024, Amgen has announced that the FDA has granted Tezspire (tezepelumab-ekko) a breakthrough therapy designation as an add-on maintenance treatment for patients with moderate to very severe COPD with a high blood count of a type of white blood cells called eosinophils.
The FDA decision comes after positive data from the COURSE clinical trial, a phase 2a study run by AstraZeneca, was presented at the annual American Thoracic Society (ATS) meeting in May this year.
The results of the trial, which recruited 333 patients with COPD, showed that Tezspire led to a reduction in the annual rate of COPD exacerbations of 17% compared to placebo after a year of treatment.
While this result was not statistically significant, the treatment did show a significant 37% reduction of exacerbations in patients with a high blood eosinophil count (BEC). The companies estimate that these patients make up approximately 65% of all COPD patients who are eligible for the treatment.
Advancing effective treatment for COPD
Along with the announcement of the breakthrough designation, Amgen reported that plans to start a phase 3 trial with Tezspire in COPD remain on track.
"The FDA's decision to grant Breakthrough Therapy Designation for tezepelumab in COPD represents a significant milestone in our commitment to advancing effective treatment options for patients with moderate to very severe disease. This recognition validates our belief in tezepelumab and its promise as a new treatment for COPD. As we advance our clinical development program, we look forward to working with the FDA to bring this potential therapy to these patients as quickly as possible," stated a company representative.
Tezspire received FDA approval in 2021 as an add-on maintenance treatment for severe asthma, which makes up approximately 10% of all asthma diagnoses. In 2023, Amgen reported $567 million in US sales for Tezspire for this indication.
In the coming years, Amgen and AstraZeneca have plans to expand the number of indications for Tezspire with a potential series of additional approvals in the US and abroad. The partners are currently running several phase 3 studies with the biologic drug as a treatment for inflammatory conditions such as chronic rhinosinusitis and eosinophilic esophagitis.
