Amgen and AstraZeneca’s Asthma Drug Flunks Phase 3 Trial
Amgen and AstraZeneca’s asthma candidate tezepelumab has just failed a critical Phase 3 clinical trial. On December 22nd, the companies announced that their drug did not satisfy the main goal of diminishing steroid dependence alongside maintaining proper respiratory conditions. News of this failure comes weeks after tezepelumab was impressive in another Phase 3 trial, leaving the companies with mismatched datasets as they gear up to seek regulatory approvals.
Tezepelumab, a thymic stromal lymphopoietin inhibitor, was previously marketed by the companies to facilitate reductions in patients with lower eosinophils levels as they looked to capture market share from competitors. In the previous Phase 3 trial, the companies showcased promising data that now seems to be in hot water based on their recent findings.
Asthma, a chronic disease that constricts, swells, and inflames airways in the lungs, is responsible for affecting more than 339 million people worldwide. An estimated 10% of the patients with severe asthma experience imperfect lung functions, which in turn affects their quality of life. Common treatments for this disease include inhaled and oral corticosteroids.
Failed Phase 3 Trial
The primary goal of this study was to prove that tezepelumab helped reduce the intake of oral corticosteroids. The second Phase 3 clinical trial consisted of 150 adults with oral corticosteroid dependent asthma who either received tezepelumab or placebo every four weeks, in addition to their existing medicines. Results showed that tezepelumab didn’t significantly reduce daily oral corticosteroid dose, thus dealing a huge blow to the companies.
The companies reiterated that they intend to analyze the data from the clinical study further in much greater detail while blaming the study design as the potential cause of failure.
Mene Pangalos, Executive Vice President of Biopharmaceuticals R&D at AstraZeneca, chimed in on the matter, saying, “Our initial analysis indicates that the trial design may have contributed to the result of the primary endpoint.”.
They intend to present their data at an upcoming medical conference.
The asthma market is getting crowded as pharma giants keep seeking FDA approvals and gain market share. The major competitors in this field are GlaxoSmithKline’s Nucala and Advair, Teva’s Cinqair, Roche and Novartis’ Xolair, AstraZeneca’s Fasenra, and Sanofi and Regeneron’s Dupixent.
In 2017 alone, Nucala raked in about £236 million in the US market, while Advair took in another £1.6 billion. Dupixent, in its first-quarter, crossed $303 million in the US. However, all this comes at a huge price tag to the patient. Experts found out that the drugs’ costs ranged between $313,000 to $464,000 (Xolair at the low end and Dupixent at the high end) per additional quality-adjusted life-year (QALY) gained, a common benchmark used to assess the cost-effectiveness of a drug.
If tezepelumab can reposition itself by analyzing their data, venturing into other avenues, or by lowering their cost, they stand a strong chance to gain a foothold in this already overcrowded market.
By T. Chakraborty, Ph.D.
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