Boehringer Ingelheim has announced that the FDA ( Food and Drug Administration ) Pulmonary-Allergy Drugs Advisory Committee ( PADAC ) has recommended that clinical data included in a new drug application ( NDA ) provide substantial and convincing evidence to support the approval of Olodaterol ( Striverdi Respimat ) as a once-daily maintenance bronchodilator treatment for airflow obstruction in patients with chronic obstructive pulmonary disease ( COPD ), including chronic bronchitis and/or emphysema.

The Committee also voted affirmatively that data showed the efficacy and a positive safety profile of Olodaterol supports approval of the 5 mcg 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 mcg 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. 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 Mist Inhaler, has been designed by Boehringer Ingelheim as a combination partner for Tiotropium for the maintenance treatment of COPD.

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.

Chronic obstructive pulmonary disease ( COPD ) is a major cause of death and disability throughout the world, and has a significant physical and emotional impact on those who suffer from the disease.
As COPD progresses, lung function declines and physical activity may become severely limited, disrupting the patient’s ability to lead a full life, interfering with everyday tasks and participation in family routines. This can lead to people feeling afraid, anxious, frustrated, isolated and depressed.
World Health Organisation ( WHO ) figures estimated that 210 million people are living with COPD. According to WHO more than 3 million people died of COPD in 2005, which corresponds to 5% of all deaths globally. However, mortality data is likely to be significantly under-estimated due to under-recognition and under-diagnosis of COPD. WHO predicts that COPD will become the third leading cause of death worldwide by 2030.
COPD patients often have other serious medical conditions, such as heart disease, diabetes, osteoporosis and depression, making treatment of COPD in parallel with these diseases even more difficult.

Source: Boehringer-Ingelheim, 2013

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