NEW YORK (AP) -- GlaxoSmithKline PLC and Theravance Inc. said Wednesday that the Food and Drug Administration expects to make a decision on their lung disease drug Breo by May 12.
The companies said the FDA accepted the application they filed in July. They said Europe Union regulators also accepted their marketing application, although they did not say when that review will be complete. The companies have asked the FDA to approve Breo as a treatment for chronic obstructive pulmonary disease, and they want the European Medicines Agency to approve the drug as a treatment for COPD and asthma.
The companies added that on Tuesday they filed for marketing approval in Japan for the COPD and asthma indications.
GlaxoSmithKline and Theravance want to market the drug as Breo if it is approved in the U.S. and as Relvar in Europe. The treatment is designed to be delivered through a new dry powder inhaler called Ellipta.
Chronic obstructive pulmonary disease leads to the narrowing of the airways to the lungs, which can cause chronic coughing and excessive phlegm. The condition is the fourth-leading cause of death in the U.S., according to the FDA.
London-based GlaxoSmithKline owns a 27-percent stake in Theravance. Its shares fell 28 cents to $46.77 in morning trading. Shares of Theravance, which is based in South San Francisco, Calif., fell 36 cents to $25.40.
- Pharmaceuticals & Drug Trials
- GlaxoSmithKline PLC
- Food and Drug Administration