Boehringer Ingelheim GmbH’s once-daily drug for a common lung disease may not ease breathing enough to offer a significant benefit to patients, U.S. regulators said, as the German drugmaker vies with companies including GlaxoSmithKline Plc to find new therapies.
The medicine, olodaterol, treats chronic obstructive pulmonary disease, Food and Drug Administration staff said today in a report ahead of a Jan. 29 meeting of agency advisers. The medicine also may not provide a significantly meaningful benefit in helping patients exercise. The FDA found “no major identified safety concerns,” the staff wrote.
Chronic obstructive pulmonary disease, often caused by cigarette smoking, is the third-leading cause of death in the U.S., according to the National Institutes of Health. London-based Glaxo and Theravance Inc., based in South San Francisco, California, are developing a similar inhaled medication that faces an advisory panel on March 7. The drugs would compete with Novartis AG’s Arcapta Neohaler, approved in 2011.
Olodaterol’s effect on patient breathing was “somewhat modest,” the FDA staff found after reviewing studies of the drug. It will be up to the advisory panel to recommend “whether or not this modest treatment effect in the setting of other baseline medication is sufficient” to warrant approval, the report said.
Deaths, heart attacks and other potential side effects “did not raise any specific or unique safety concerns” in COPD patients. Studies also found no asthma-related deaths or increase in problems related to asthma, the FDA staff said.
Boehringer, the world’s biggest family-owned drugmaker, has proposed selling the drug in a metered-dose inhaler called Striverdi Respimat. The company is based in Ingelheim.
Boehringer compared patients who took olodaterol daily and others who used half a dose of the drug twice a day and found both improved lung function at a significant and identical rate, the company said after releasing results of the second of what are typically three phases of clinical trials.
Chronic obstructive pulmonary disease is a condition that includes chronic bronchitis and emphysema. The illness constricts air flow because the air sacs of the lungs are damaged or the airways become clogged, according to the NIH.
Boehringer is studying a once-daily combination of olodaterol and tiotropium. Tiotropium is the active ingredient in Boehringer and New York-based Pfizer Inc.’s Spiriva, approved in 2004, that relaxes airway muscles and helps keep them open.
Novartis, based in Basel, Switzerland, and Glaxo also are researching combination products for chronic obstructive pulmonary disease.
Forest Laboratories Inc. and Almirall SA won FDA approval in July for their Tudorza Pressair, a twice-daily inhaled powder to treat bronchospasms associated with the disease. New York-based Forest and Barcelona-based Almirall are studying a combination involving aclidinium bromide, the active ingredient in Tudorza.