AstraZeneca's first respiratory biologic preparation Fasenra slow-resistance lung test failed again
May 31, 2018 Source: Sina Pharmaceutical
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];Recently, AstraZeneca’s hopes of expanding the asthma drug Fasenra indication to chronic obstructive pulmonary disease (COPD) have shattered. On Wednesday, the British drugmaker announced the failure of the drug's chronic obstructive pulmonary phase III trial, TERRANOVA, which is the second drug trial for patients with moderate to severe chronic obstructive pulmonary disease.
In this trial, Fasenra missed the primary endpoint of the study. When the patient's symptoms suddenly deteriorated, taking the drug did not significantly reduce the onset of the disease. The test failed, and it is undoubtedly good news for GlaxoSmithKline, the competitor in the same field. AstraZeneca issued a similar statement earlier this month to publish top-line data from the third-phase clinical study GALATHEA for moderate to very severe COPD. The results showed that the study failed to reach a primary endpoint that resulted in a statistically significant reduction in the severity of COPD.
AstraZeneca's Phase III clinical trial of Fasenra Chronic Obstructive Pulmonary Disease consists of two Phase III studies, enrolling nearly 4,000 patients, and is the largest COPD biologics development project ever undertaken. Both were randomized, double-blind, 56-week placebo-controlled, multicenter studies conducted in patients with moderate to very severe COPD across a range of baseline eosinophil levels and with a history of previous exacerbations, assessed Fasenra as An add-on therapy for double or triple therapy compared to placebo.
In the fierce competition with GlaxoSmithKline, the failure of Fasenra to treat the COPD test was a major setback for AstraZeneca. Fasenra is the first respiratory biologic formulation developed by AstraZeneca and the only respiratory biologic therapy that provides direct, rapid, almost complete depletion of eosinophils within 24 hours of dosing. Up to now, the drug has been approved for severe eosinophilic asthma in the United States, the European Union, Japan and several other countries and regions.
Fasenra is also the third IL-5 inhibitor anti-inflammatory drug listed after GlaxoSmithKline Nucala and Teva Cinqaero. All three drugs have been approved for the treatment of severe eosinophilic asthma. The first two target IL-5, in which Nucla is injected subcutaneously once a month, and Cinqaero is infused once a month. These two drugs can lower blood by inhibiting the binding of IL-5 to eosinophil surface receptors. Eosinophil levels in tissues and sputum. Fasenra is injected subcutaneously every 2 months (8 weeks), and IL-5R targeting the surface of eosinophils directly depletes eosinophils. AstraZeneca hopes that the convenience of the drug will capture the market share of Glaxo.
However, unlike Fasenra, Nucala has been shown to improve patient deterioration. In Phase 3 studies, the drug showed a moderate and severe frequency of disease in patients with higher eosinophil counts in the blood, which is also a targeted biomarker for such drugs.
Now, GlaxoSmithKline is waiting for the final decision of the US FDA on the drug. If it is finally passed, it will undoubtedly be a heavy blow to AstraZeneca. In addition to asthma and chronic obstructive pulmonary disease, Nucala has also been approved for other indications. Last December, the drug was approved for the treatment of eosinophilic granuloma with polyangiitis, a chronic rare disease caused by inflammation of the blood vessel wall. (Sina Pharmaceutical Compilation / Fan Dongdong)
Article reference source: AstraZeneca's Fasenra fails its second COPD trial, handing rival GSK a win
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