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AZ severe asthma drug benralizumab backed by CHMP

The IL-5 inhibitor set for European approval to treat severe eosinophilic asthma


AstraZeneca has taken a step closer to re-invigorating its respiratory business with a positive opinion in the EU for benralizumab, its IL-5 inhibitor for severe asthma.

The Committee for Medicinal Products for Human Use (CHMP) backed approval of benralizumab at its committee meeting late last week as an add-on maintenance treatment for severe eosinophilic asthma in patients who can’t control symptoms using high-dose inhaled corticosteroids plus long-acting beta agonist drugs.

In trials, benralizumab achieved up to 51% reduction in the annual asthma exacerbations rate (AERR) versus placebo, with 75% of patients on the drug reducing their use of oral corticosteroids - which are linked to potentially serious side effects if used over a protracted period - and around half (52%) able to do away with them altogether.

AZ is vying to make the drug the third IL-5 inhibitor to reach the market for severe asthma after GlaxoSmithKline’s Nucala (mepolizumab) and Teva's Cinqaero (reslizumab), and says benralizumab is “the first respiratory biologic with an eight-week maintenance dosing schedule”.

Despite a third-to-market position, AZ chief medical officer Sean Bohen said: “Benralizumab has the potential to make a real difference to patients with its combination of efficacy, speed of onset, convenience and the ability to reduce oral steroid use.”

Nucala has got off to a fair start in the market, bringing in £213m ($279m) for GSK in the first nine months of the year, while Teva did not break out sales of its drug in its third quarter results statement. AZ will be hoping benralizumab’s profile will help it catch the leaders, despite an increasingly competitive landscape in severe asthma.

Benralizumab has assumed much greater importance for the company since IL-13 inhibitor tralokinumab - another severe asthma candidate - failed two phase III trials. The drugmaker has also a third asthma hopeful - Amgen-partnered thymic stromal lymphopoietin (TSLP) targeting antibody tezepelumab - which aced phase II trials in asthma but flunked a phase III trial earlier this month in atopic dermatitis.

Last year AZ's respiratory pipeline suffered another setback after the company halted a phase IIa trial of a Synairgen-partnered inhaled interferon beta formulation (AZD9412) for asthma, deciding it was unlikely to give conclusive results.

Article by
Phil Taylor

13th November 2017

From: Regulatory



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