The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has recommended approval for a new drug called olodaterol in the treatment of patients with chronic obstructive pulmonary disease (COPD).
The drug provides treatment for airflow obstruction in COPD patients, including chronic bronchitis and emphysema.
The FDA advisory committee made the recommendation based on clinical data included in the drug’s new drug application (NDA), according to its manufacturer, Boehringer Ingelheim Pharmaceuticals Inc.
The FDA Committee reviewed data from a Phase 3 olodaterol clinical trial program, including data from 48-week and 6-week duration trials.
Results found that olodateral improved lung function in patients with moderate to very severe COPD, as compared to patients given a placebo. The most commonly reported adverse reactions were nasopharyngitis, dizziness, rash, and arthralgia, according to Boehringer Ingelheim.
“The positive vote from the Advisory Committee marks an important step towards making olodaterol available to the approximately 24 million patients with COPD in the United States,” said Tunde Otulana, MD, vice president of clinical development and medical affairs at Boehringer Ingelheim.
The drug may also provide benefits for exercise tolerance in COPD patients, an important part of COPD management.
“Patients with COPD often have impaired exercise tolerance because lung hyperinflation develops during exercise,” said Richard Casaburi, PhD, MD, a professor of medicine at the UCLA School of Medicine. “Improving exercise tolerance is a critical component of COPD management strategies.”