It's official. Regeneron and Sanofi need not be concerned about Dupixent competition from tezepelumab for the skin condition called atopic dermatitis. Dupixent's asthma franchise, though, is still in AstraZeneca's sight.
AstraZeneca has removed tezepelumab from its clinical atopic dermatitis development pipeline, according to its second quarter results released (PDF) early Thursday morning. The action comes one year after AstraZeneca’s partner Amgen revealed it had stopped a phase 2 trial in the indication based on the efficacy data.
Amgen since terminated the phase 2 study on the grounds that “tezepelumab as a monotherapy … did not reach the targeted efficacy level pre-established for this patient population,” the U.K. Big Pharma said in its second quarter results.
Yet, while Amgen dropped atopic dermatitis from the list of indications targeted by the anti-thymic stromal lymphopoietin monoclonal antibody last year, the program remained in AstraZeneca’s pipeline.
That all changed Thursday, when AstraZeneca removed tezepelumab in atopic dermatitis from its pipeline as part of its second quarter update. Besides the terminated phase 2 trial, another atopic dermatitis study had failed back in 2017.
While tezepelumab has failed in atopic dermatitis, it has delivered better results in other indications, most notably asthma. The FDA granted priority review to tezepelumab in asthma earlier this month, setting the agency up to make an approval decision in the first quarter of next year. The filing is supported by evidence that tezepelumab works in patients with low levels of eosinophils.
That data position Amgen and AstraZeneca to target the population of noneosinophilic asthma patients, who have limited treatment options while drugs such Dupixent have improved the lives of those with the eosinophilic form of the condition.
Regeneron and Sanofi have succeeded in establishing Dupixent, also known as dupilumab, as a treatment for both asthma and atopic dermatitis. Tezepelumab has failed to generate the data to follow Dupixent to market in atopic dermatitis but still has other shots on goal beyond asthma.
A phase 3 trial in patients with severe chronic rhinosinusitis with nasal polyposis got underway in April. Also, a mid-phase trial in chronic obstructive pulmonary disease is still going, and Amgen began a phase 2 study in chronic spontaneous urticaria earlier this year.