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GSK wins US approval for Seretide successor Breo Ellipta

FDA gives green light to COPD combination

GSK GlaxoSmithKline house

GlaxoSmithKline's new long-term, once-daily, maintenance therapy for chronic obstructive pulmonary disease (COPD) has been approved in the US.

The FDA licensed Breo Ellipta to treat airflow obstruction in patients with COPD, including chronic bronchitis and emphysema, and said it can also be used to reduce exacerbations of COPD.

The treatment combines GSK's inhaled corticosteroid fluticasone furoate (which it markets as Avamys/Veramyst) and the newer vilanterol inhalation powder, which is a long-acting beta2-adrenergic agonist (LABA).

Darrell Baker, SVP and head of GSK's global respiratory franchise, said: “This approval means that we can now realise our plan to bring Breo Ellipta to appropriate COPD patients in the US. 

“We know that one of the main issues for patients who have experienced a COPD exacerbation is concern about possible future episodes. Breo Ellipta will help patients breathe better day-to-day and reduce the risk of future exacerbations, with a once-daily inhalation.”

COPD, whose symptoms can include chest tightness, chronic cough and excessive phlegm, worsens over time and is the third leading cause of death in the US.

Breo Ellipta, which was jointly developed by GSK and US biopharma company Theravance, works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed.

Rick Winningham, Theravance's CEO, said: “The FDA approval of Breo Ellipta brings an important inhaled, once-daily maintenance therapeutic option to COPD patients and doctors across the United States. After more than a decade of joint respiratory research and development, the approval is a very important milestone for Theravance and GSK.”

The partners plan to launch Breo Ellipta in the US during the third quarter of this year. But it will have to carry a boxed warning that LABAs increase the risk of asthma-related death and the FDA warned that Breo Ellipta could cause serious side effects, including increased risks of pneumonia and bone fractures.

The combination is currently being considered by European regulatory authorities and if approved GSK plans to sell it as Relvar. 

Breo Ellipta is one of a number of drugs GSK is looking to replace its big-selling Seretide/Advair (fluticasone propionate and salmeterol) product, sales of which are around $8bn in asthma and COPD but have slowed with the start of generic competition in some markets.

Breo Ellipta's FDA approval follows the US and EU filings of umeclidinium bromide, another of GSK's COPD drugs that's also designed to be used with the Ellipta inhaler.

Meanwhile another COPD combination, this time bringing together umeclidinium bromide and vilanterol, was filed for EU approval in January. If approved this drug would be marketed as Anoro.

13th May 2013

From: Sales

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