) and partner
) 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
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
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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.
Biogen Idec Inc.
) look well placed. Both stocks carry a Zacks Rank #1 (Strong