GSK seeking approval of lung drug Relovair by mid-2012

British pharmaceutical giant GlaxoSmithKline is hoping to gain regulatory approval for a new chronic obstructive pulmonary disease (COPD) treatment by mid-2012, it has said today.

Although clinical trials of its once-a-day inhaled drug Relovair didn’t show any superiority over GSK’s existing COPD treatment Advair, the company is confident of the new drug’s potential.

GSK believes Relovair’s once-a-day dose requirement will prove to be popular in the market because of its convenience.

It is also hoped that it will act as a valuable replacement for the current market leader Advair, which needs to be taken twice a day, when its patent protection expires.  

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Advair is GSK’s biggest selling drug, regularly earning the company over $8 billion in sales a year.

While developing the new drug, GSK worked with the US-based company Theravance Inc.

Together the two companies are now planning to file for its approval as a COPD treatment in both Europe and America by mid-2012.

Relovair is also being submitted as a treatment for asthma in Europe and the two companies are still involved in discussions with regulators about its use for asthma sufferers in America.

Darrell Baker, the head of respiratory medicine development at GlaxoSmithKline was pleased with the progress of Relovair.

He said: “We are pleased to have reached this milestone for Relovair, one of the important assets in our respiratory development portfolio.

“Having undertaken an initial assessment of these data we believe they support our plan to seek global approvals of this once-daily medicine for the treatment of patients with COPD and asthma,” he added.

Meanwhile, the CEO of Theravance, Rick E Winningham, commented: “We are very excited with the new data and GSK's plan to submit regulatory applications for Relovair in the US and Europe this year.

“Relovair is one of our three respiratory programs with GSK.”

Industry analysts have predicted that should it receive approval, Relovair will emerge on the market in 2013.

They have also said if the drug proves to be a popular medication for COPD and asthma as GSK and Theravance are hoping, by 2016 it could have amassed $1.88 billion in sales.

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