Boehringer Ingelheim GmbH, the world’s biggest family-owned drugmaker, won the backing of U.S. regulatory advisers for a drug to treat a lung disease that is the nation’s third-leading cause of death.
Boehringer provided sufficient data to support approval of the medicine olodaterol to treat chronic obstructive pulmonary disease, advisers to the Food and Drug Administration voted 15-1 today. Agency staff had questioned whether the medication eased breathing enough to offer a significant benefit to patients in a report ahead of today’s meeting in Silver Spring, Maryland.
Boehringer is vying with GlaxoSmithKline Plc, Novartis AG and other companies to develop new therapies for COPD, an umbrella term for lung ailments that restrict air flow such as chronic bronchitis and emphysema. Boehringer, based in Ingelheim, Germany, has proposed selling its drug in a soft mist inhaler called Striverdi Respimat.
“It was a great thing they did and the best we have right now and I believe it’s going to push us in a more comprehensive fashion in the future,” Bill Ameredes, a panel member and associate professor at the University of Texas Medical Branch’s pulmonary division in Galveston, said during the meeting.
Advisers voted 15-1 that the company provided substantial evidence the drug works for long-term, once-daily maintenance of COPD. They also voted by the same margin that olodaterol is safe enough to support approval.
“A once-a-day is preferable to patients, including myself,” Michelle Harkins, associate professor in the University of New Mexico’s Department of Internal Medicine in Albuquerque, said during the meeting.
Many panel members said the company shouldn’t be able to make claims on the label that the drug can provide a benefit in helping patients exercise.
Boehringer also should do studies after approval to monitor benign and malignant tumors that develop in some people taking the drug, panel members said. Of those taking olodaterol in a clinical trial, 14 on a 5-microgram dose developed tumors and 19 on a 10-microgram dose developed tumors, according to the FDA staff report. Nine people on placebo developed the malignancies as well.
An imbalance of tumors in the olodaterol groups were lung-related, FDA staff said in its report last week.
COPD, often caused by cigarette smoking, constricts air flow because the air sacs of the lungs are damaged or the airways become clogged, according to the National Institutes of Health.
Boehringer also 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 COPD.
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.