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Theravance/Glaxo’s Breo Ellipta wins FDA go-ahead

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Theravance/Glaxo's Breo Ellipta wins FDA go-ahead

GlaxoSmithKline (NYSE:GSK) and Theravance (NSDQ:THRX) won FDA approval for their co-developed Breo Ellipta inhaler for treatment of airflow obstructions, including bronchitis and emphysema in patients with chronic obstructive pulmonary disease.

The once daily, long-term maintenance inhaler is also indicated to reduce COPD exacerbations in patients with a history of such flare-ups, the companies said.

Breo Ellipta is a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist vilanterol and is delivered to the patient using Theravance’s Ellipta, a new dry powder inhaler.

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

Theravance and GlaxoSmithKline anticipate rolling out Breo Ellipta in the U.S. during the third quarter of fiscal 2013. Under previously set terms, FDA approval of Breo Ellipta obligates Theravance to make a milestone payment of $30 million to GSK.

The National Heart, Lung and Blood Institute estimates that as many as 27 million people in the US alone are affected by COPD, a number that is predicted to increase, the companies pointed out.

"This approval means that we can now realize our plan to bring Breo Ellipta to appropriate COPD patients in the U.S.," head of GSK Global Respiratory Franchise Darrell Baker said in a press statement. "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."

GlaxoSmithKline and Theravance are also seeking regulatory approval of the inhaler, under the trade name Relvar Ellipta, in Europe and Japan, the companies said.

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