FDA accepts filing (BLA) of reslizumab for eosinophil elevated asthma- Teva

Teva Pharmaceutical Industries Ltd., announced that the FDA has accepted for review the Biologics License Application (BLA) for reslizumab, the company�s investigational humanized 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.

The BLA for reslizumab includes data from Teva�s Phase III BREATH clinical trial program. The program 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. Common adverse events in the reslizumab treatment group were comparable to placebo and included worsening of asthma, nasopharyngitis, upper respiratory infections, sinusitis, influenza and headache. Two anaphylactic reactions were reported and resolved following medical treatment at the study site. Results from the reslizumab BREATH program were recently presented at the American Thoracic Society 2015 Annual Meeting and the American Academy of Allergy, Asthma and Immunology 2015 Annual Meeting, in addition to being published in The Lancet Respiratory Medicine. The BLA for reslizumab has been accepted for filing by the FDA for standard review, with FDA Regulatory Action expected in March 2016.

See: "Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials"- Cited in Scopus: 0 Mario Castro, James Zangrilli, Michael E Wechsler, Eric D Bateman, Guy G Brusselle, Philip Bardin, and others The Lancet Respiratory Medicine, Vol. 3, No. 5, p355�366 Published online: February 23, 2015.

Comment: GlaxoSmithKline�s mepolizumab, a further IL-5 product has just received a unanimous recommndation for approval from FDA advisers for adults (but not adolescents).