FDA accepts Teva asthma drug for review
pharmafile | June 15, 2015 | News story | Sales and Marketing | AstraZeneca, GlaxoSmithKline’s mepolizumab, Teva, benralizumab, bla, cinquil, reslizumab
Teva’s investigational biologic for the treatment of inadequately controlled asthma in patients with elevated blood eosinophils, Cinquil, has been accepted for review by the FDA.
The US regulator has acknowledged the Biologics License Application (BLA) for Cinquil (reslizumab), the company’s investigational humanised monoclonal antibody (mAb) which targets interleukin-5 (IL-5), for the treatment of inadequately controlled asthma in adult and adolescent patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based regimen.
“Despite currently available medicines, uncontrolled asthma remains a serious problem for patients, physicians and healthcare systems, highlighting the need for targeted new treatment options,” says Dr Michael Hayden, president of Global R&D and chief scientific officer at Teva.
The Israeli firm believes the BLA filing acceptance to be a significant milestone for the company as it works toward serving a specific asthma patient population that is defined by elevated blood eosinophil levels – and inadequately controlled symptoms despite standard of care therapy.
“In clinical trials, patients treated with reslizumab showed significant reductions in the rate of asthma exacerbations and significant improvement in lung function. If approved, we believe reslizumab will serve as an important new targeted treatment option to achieve better asthma control for patients with eosinophil-mediated disease,” Hayden adds.
The BLA for reslizumab includes data from Teva’s Phase III BREATH clinical trial programme, which consisted of four separate placebo-controlled Phase III trials involving more than 1,700 adult and adolescent asthma patients with elevated blood eosinophils, whose symptoms were inadequately controlled with inhaled corticosteroid-based therapies.
Results from these studies demonstrated that reslizumab, in comparison to placebo, reduced asthma exacerbation rates by at least half and provided significant improvement in lung function and other secondary measures of asthma control when added to an existing ICS-based therapy.
Data from the reslizumab BREATH programme were recently presented at the American Thoracic Society 2015 Annual Meeting, in addition to being published in The Lancet Respiratory Medicine.
Teva’s offering will be rubbing shoulders in the marketplace with other drug candidates in late-stage trials for severe asthma, such as AstraZeneca’s benralizumab but also GlaxoSmithKline’s mepolizumab – which has just been backed by an FDA panel.
The BLA for reslizumab has been accepted for filing by the FDA for standard review, with FDA Regulatory Action expected in March 2016.
Brett Wells
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