Teva Pharmaceutical Industries Ltd. TEVA announced that the FDA’s Pulmonary Allergy Drugs Advisory Committee has recommended the approval of its biologic, reslizumab.
Reslizumab, a humanized anti-interleukin-5 (IL-5) IgG4K monoclonal antibody (mAb), is being developed for the treatment of inadequately controlled asthma in patients with elevated blood eosinophils, despite an inhaled corticosteroid (ICS)-based treatment regimen in adult patients above 18 years of age.
We note that the FDA generally takes the advisory committee's recommendation into consideration when reviewing candidates but is not bound by the same. The Biologics License Application (BLA) for reslizumab was accepted by the FDA for review in Jun 2015 and a decision is expected by Mar 2016.
Reslizumab is currently under review in the EU as well.
In Sep 2015, Teva presented encouraging data from a post hoc analysis of two pivotal phase III studies on reslizumab at the European Respiratory Society International Congress 2015. Results from the trials showed that treatment with reslizumab reduced clinical asthma exacerbations by 75% compared to placebo in a subgroup of patients with late-onset asthma (diagnosed at 40 years of age and older) with elevated blood eosinophils, who were inadequately controlled on ICS.
A potential approval in the EU and the U.S. will further strengthen Teva’s portfolio, though the going may not be easy given existing players in the same space.
We remind investors Novartis’ NVS Xolair is also approved for the treatment of moderately to severely persistent allergic asthma in the U.S. and the EU.
Teva carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Mylan MYL and Pfizer, Inc. PFE. Both carry a Zacks Rank #2 (Buy).
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