GSK, Theravance hit up regulators for approval of key asthma/COPD drug

GlaxoSmithKline ($GSK) and Theravance ($THRX) have turned in applications for approval of the partners' lead COPD/asthma drug with U.S. and European regulators. The once-daily LABA drug, formerly known as Relovair, is part of GSK's plan to provide next-generation respiratory drugs as its blockbuster Advair franchise fades.

London-based GSK has spotlighted the LABA (long-acting beta agonist) drug as one of the key prospects in its late-stage pipeline. The drug is one of three featured respiratory programs under development with Theravance, of South San Francisco, which has also joined forces with the drug giant on a promising LABA/LAMA program. As Reuters reports, Advair is an $8 billion drug for GSK. And GSK has invested heavily in several potential sequels to the blockbuster.

In the U.S., the partners have asked the FDA to approve their lead respiratory contender for once-daily treatment of chronic obstructive pulmonary disease (COPD) under the brand name Breo. The companies won't initially ask for approval for asthma, but it's not off the discussion table, according to their release. In Europe, however, the companies want nods for both the COPD and asthma indications right off the bat, seeking to market the drug in Europe as Relvar.

- here's the release
- see Reuters' brief