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UPDATED: GSK and Theravance make progress in FDA review of key COPD drug

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GlaxoSmithKline has made progress with one piece of the puzzle to maintain its dominance in the respiratory drug market. The London-based drug giant ($GSK) and partner Theravance ($THRX) said today that the FDA has accepted their application for approval for their FF/VI drug Relvar/Breo for chronic obstructive pulmonary disease (COPD), with the agency giving the companies a May 12, 2013 action date on the app.

The once-daily inhaled drug, formerly known as Relovair, offers GSK a new weapon in its arsenal of respiratory drugs that includes best-selling Advair. Relvar has thus far brought mixed results in clinical trials, yet GSK has a slate of next-gen respiratory treatments. And the company touted the potential of its and South San Francisco-based Theravance's MABA drug known as GSK961081--which showed promising results in mid-stage studies--as a potential first-of-its kind treatment for COPD patients.

Yet that program is years behind Relvar, which GSK and Theravance have also submitted for approval in the European Union for both COPD and asthma. Glaxo said today that the European Medicines Agency has validated that application, and that yesterday the company filed for approval of the drug for COPD and asthma patients in Japan, where it plans to market the drug as Relvar. The drug hasn't yet been approved anywhere.

Glaxo has a lot at stake in the respiratory market, where it now leads all pharma peers in sales, largely because of Advair, Reuters has reported. That sets some serious expectations for its pipeline contenders in the fields, with the added pressure of Swiss rival Novartis ($NVS) laying out a blockbuster agenda for its potential COPD treatment QVA149, which gained significant attention for data presented at the European Respiratory Society meeting in Vienna earlier this month.

- here's GSK's release

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