GSK seeking approval of lung drug Relovair by mid-2012

By Admin
British pharmaceutical giant GlaxoSmithKline is hoping to gain regulatory approval for a new chronic obstructive pulmonary disease (COPD) treatment by...

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.  

To read the latest edition of Healthcare Global, click here

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.

The Healthcare Global magazine is now available on the iPad. Click here to download it.

Share

Featured Articles

McKinsey: Women More Likely to die of Heart Attack Than Men

McKinsey Health Institute's Lucy Pérez says cardiovascular disease top killer of women yet physicians don't know their heart attack symptoms are different

Novo Nordisk Buys $1bn Cardior in CardioVascular Move

As Novo Nordisk expands into heart medicines, we profile the Danish pharma giant who in 1923 was the first to make insulin commercially available

Shoddy Chinese Syringes Sees BD Ramp-up Production

Becton Dickinson – a major supplier of syringes – said it has upped manufacturing in its US facilities after FDA warning on China-made products

AI Tool 'Picks up Early-stage Breast Cancers Doctors Missed'

Technology & AI

AstraZeneca Buys $2bn Fusion in Next-gen Cancer Drugs Move

Medical Devices & Pharma

Eli Lilly and Amazon Pharmacy Partner on Drugs Delivery

Digital Healthcare