Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) recommended that clinical data included in a new drug application (NDA) provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
“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 NDA,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “The positive vote from the Advisory Committee marks an important step towards making once-daily olodaterol, which is designed to add additional bronchodilation in combination with tiotropium, available to the estimated 210 million patients with COPD worldwide.”
The Committee also voted affirmatively that data showing the efficacy and a positive safety profile of olodaterol supports approval of the 5µg dose.
The Committee reviewed data from the Phase 3 olodaterol clinical trial programme, including data from the 48-week and 6-week duration trials. These data are part of the NDA being reviewed to establish that olodaterol delivered once-daily at the 5 µg dose showed improvements in lung function, as measured by forced expiratory volume in one second (FEV1), over at least 24 hours, in patients with moderate to very severe COPD compared to placebo and also active comparators.
The trials were conducted in a patient population representative of those seen in clinical practice.3A,C Overall olodaterol was well tolerated. The most commonly reported adverse reactions were nasopharyngitis, dizziness, rash, and arthralgia. Patients involved in the studies were allowed to continue on their usual care with the exception of long-acting beta agonists. Usual care included long- and short-acting anticholinergics, short-acting beta agonists, inhaled corticosteroids and xanthenes.
Olodaterol, delivered in the new generation inhaler Respimat® Soft MistTM Inhaler, has been designed by Boehringer Ingelheim as a combination partner for tiotropium for the maintenance treatment of COPD.
Full results from the Phase 3 studies included in the olodaterol NDA will be presented at future medical meetings.
In addition to the 48-week and 6-week duration studies assessing the safety and efficacy of olodaterol, the Committee also reviewed a set of replicate studies evaluating the impact of olodaterol on exercise tolerance in COPD patients. This is the first time a company has sought inclusion of exercise tolerance data in a COPD product’s label.
“Patients with COPD often have impaired exercise tolerance because lung hyperinflation develops during exercise,” said Richard Casaburi, PhD, MD, Professor of Medicine, UCLA School of Medicine. “Improving exercise tolerance is a critical component of COPD management strategies.”