A U.S. Food and Drug Administration committee has recommended the approval of GlaxoSmithKline PLC (GSK.LN, GSK) and Theravance Inc.'s (THRX) Anoro Ellipta as a treatment for chronic obstructive pulmonary disease.
GlaxoSmithKline American depositary shares were off by five cents to $50.41 in recent trading. Theravance shares, which had been halted all day ahead of the news, have climbed 70% since the start of the year and previously closed at $37.79.
The companies said the FDA's Pulmonary-Allergy Drugs Advisory Committee voted 11 to 2 that the efficacy and safety data provide substantial evidence to support approval of umeclidinium/vilanterol, which has the proposed proprietary name of Anoro Ellipta,for long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. If approved, Anoro Ellipta will be the first once-daily dual bronchodilator available in the U.S.
The companies submitted a new drug application for the use of UMEC/VI administered by the Ellipta inhaler for the long-term once-dailytreatment of airflow obstruction in patients with COPD. UMEC/VI is an investigational medicine and is not currently approved anywhere in the world.
In April, Theravance said it plans to create two independent publicly traded companies, separating its late-stage partnered respiratory assets from its biopharmaceutical operations.
The FDA in May approved Breo Ellipta, a drug developed by GlaxoSmithKline and Theravance, to treatCOPD. Breo Ellipta, which is administered once-daily with an inhaler, is seen initially as a complementary product to the U.K. drug giant's top-selling asthma drug Advair, which generates around $8 billion a year in sales, but could, in the long term, replace it.
COPD, marked by damaged lungs, is the third-leading cause of death in the U.S., according to the National Institutes of Health. The disease, which is primarily caused by smoking, causes the lungs' airways to become partly obstructed.
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