RIDGEFIELD, Conn. — A panel of Food and Drug Administration experts has recommended approval for an experimental drug made by Boehringer Ingelheim for chronic obstructive pulmonary disease, the drug maker said.
BI announced that the FDA's Pulmonary-Allergy Drugs Advisory Committee recommended approval of the drug olodaterol, which the company plans to market under the name Striverdi Respimat. The drug is a once-daily bronchodilator treatment for airflow obstruction in patients with COPD, including chronic bronchitis and emphysema. The FDA is not required to follow advisory committee decisions when deciding whether or not to approve a drug, but usually does.
"We at Boehringer Ingelheim are pleased with the advisory committee's recommendation and look forward to continuing to work with the FDA as the agency continues its review of the olodaterol [new drug application]," BI Pharmaceuticals VP clinical development and medical affairs for respiratory Tunde Otulana said. "The positive vote from the advisory committee marks an important step toward making olodaterol available to the approximately 24 million patients with COPD in the United States."