GlaxoSmithKline Plc (GSK) and Theravance Inc. (THRX:US)’s once-daily drug Relvar for respiratory disorders was recommended for approval by the European Union’s drug regulator.
The dry powder inhaler may be used to treat asthma or exacerbations of chronic obstructive pulmonary disease, or COPD, and airflow obstruction, the London-based company and its U.S. partner said in a statement. COPD, often caused by cigarette smoking, is an umbrella term for emphysema and chronic bronchitis. The drug, to be marketed as Breo in the U.S., was cleared by the Food and Drug Administration on May 10.
Relvar may generate $992.8 million in worldwide sales by 2017, according to the average estimate of 10 analysts surveyed by Bloomberg. The once-a-day treatment will compete with twice-daily products, including Glaxo’s Advair and AstraZeneca Plc’s Symbicort.
The agency’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 28-nation bloc. Glaxo shares rose 0.3 percent to 1,580.50 pence at 9:05 a.m. in London trading.
Relvar works by decreasing inflammation in the lungs and helping the muscles around the airways stay relaxed. The treatment is a combination of the compound vilanterol and a corticosteroid.
In the U.S., Breo carries a boxed warning that drugs like it can increase the risk of asthma-related death. The drug isn’t recommended for people younger than 18 years old and can increase users’ risk of pneumonia and bone fractures, the FDA said.
Glaxo and Theravance are also working on another treatment for chronic obstructive pulmonary disease, called Anoro. The once-daily medicine combines vilanterol with another ingredient to improve lung function. The FDA is expected to decide whether to approve Anoro in December.
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