Theravance, Inc. (THRX) and partner GlaxoSmithKline (GSK) announced recently that the European Medicines Agency's (:EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of their candidate fluticasone furoate/vilanterol (FF/VI) (proposed brand name: Relvar Ellipta) in the EU. A final decision from the European Commission is expected by year end.
The CHMP recommended the approval of the candidate for the regular treatment of asthma in adults and adolescents (aged above 12 years) in cases where treatment by a combination therapy is appropriate. Approval was also recommended for treating asthma patients whose disease was not sufficiently controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.
The CHMP also backed the candidate for the symptomatic treatment of adults suffering from chronic obstructive pulmonary disease (:COPD). The positive opinion was based on results from eleven studies in 7,851 COPD patients and 16 studies in 9,326 asthma patients.
We remind investors that in May 2013, the U.S. Food and Drug Administration (:FDA) approved the candidate (trade name: Breo Ellipta) as a long-term maintenance therapy of airflow obstruction and for bringing down exacerbations in patients suffering from COPD. The candidate has also gained Canadian approval for COPDS with the same trade name. The candidate is under review in Japan (proposed brand name Relvar Ellipta) for the asthma indication. We are positive on Theravance’s pipeline programs in collaboration with Glaxo.
We note that Glaxo and Theravance are also looking to get another COPD candidate approved. In Feb 2013, the FDA accepted the regulatory application of Glaxo/Theravance’s UMEC/VI (proposed trade name: Anoro Ellipta). The companies are looking to get the candidate approved in the U.S. as a once daily therapy for treating patients suffering from COPD. A decision from the U.S. regulatory body on the candidate’s marketing application is expected by Dec 18, 2013.
Theravance carries a Zacks Rank #3 (Hold). Companies like Gilead Sciences Inc. (GILD) and Biogen Idec Inc. (BIIB) look well placed. Both stocks carry a Zacks Rank #1 (Strong Buy).
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