31 Jan 2013, BioSpectrum Bureau , BioSpectrum
Singapore: The US FDA Pulmonary-Allergy Drugs Advisory Committee (PADAC) has recommended that clinical data be included in a new drug application (NDA) providing evidence to support the approval of Boehringer Ingelheim's 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.
Professor Klaus Dugi, corporate senior VP, medicine, 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 reviewed data from the phase III olodaterol clinical trial programme, including data from the 48-week and six-week duration trials. These data are part of the NDA, which is being reviewed to establish that olodaterol when 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 as compared to placebo and also active comparators.
The trials were conducted in a patient population representative of those seen in clinical practice. 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, which is delivered in the new generation, Respimat Soft Mist Inhaler, has been designed by Boehringer Ingelheim as a combination partner for tiotropium for the maintenance treatment of COPD.