COPD Rx Closer to Approval

COPD treatment with olodaterol recommended for approval by FDA advisory committee

(RxWiki News) A medication's journey from creation to approval is a long one. One new COPD medication may be nearing the end of that journey.

An advisory committee to the US Food and Drug Administration (FDA) has recommended that there is enough convincing evidence to approve olodaterol as a once-daily treatment for airflow blockage in patients with chronic obstructive pulmonary disease (COPD).

COPD is the name used for chronic bronchitis and/or emphysema - two conditions that make it difficult to breathe. Olodateral - which is manufactured by Boehringer Ingelheim - is designed to open the bronchi and bronchioles (two parts of the airway) so that COPD patients can breathe more easily.

Although the advisory committee has recommended approval, more research is needed to fully establish the safety and effectiveness of the medication. If approved, olodaterol will be delivered through a new type of inhaler called Respimat Soft Mist.

"Keep up-to-date with new treatments for your COPD."

"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," said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim, in a press release from his company.

"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," said Professor Dugi.

The recommendation for approval comes after the FDA's Pulmonary-Allergy Drugs Advisory Committee reviewed results from a phase 3 clinical trial program of olodaterol. 

The trials involved a patient population similar to that seen in real-world clinics and included a 48-week treatment period and a six-week treatment period. Participants were allowed to continue their usual care, which included medications such as short-acting anticholinergics, short-acting beta agonists, inhaled steroids and xanthenes.

Results showed that a once-daily 5-µg dose of olodaterol led to improved lung function in patients with moderate to very severe COPD, compared to treatment with placebo (fake medication) or other treatments.

The trials also showed that olodaterol was well tolerated. The most common side effects were nasopharyngitis (inflammation of nasal cavity and throat), dizziness, rash and arthralgia (joint pain).

It's important to note, however, that these results have yet to be peer-reviewed and published. According to a Boehringer Ingelheim press release, results from the phase 3 studies will be presented at future medical meetings.

On top of reviewing the 48-week and six-week studies, the advisory committee also looked at a set of replicate studies assessing the effect of olodaterol on COPD patients' ability to exercise.

"Patients with COPD often have impaired exercise tolerance because lung hyperinflation develops during exercise," said Richard Casaburi, PhD, MD, Professor of Medicine at UCLA School of Medicine. "Improving exercise tolerance is a critical component of COPD management strategies."

Olodaterol is still in testing. Researchers have yet to fully establish the safety and effectiveness of the medication.

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Review Date: 
January 31, 2013