|Spiriva Respimat--Courtesy of Boehringer Ingelheim|
The FDA's Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 10-3 to recommend approval of Boehringer Ingelheim's mist formulation of its dry-powder inhalable treatment for chronic obstructive pulmonary disease (COPD). If approved, the new product, Spiriva Respimat, would give clinicians an alternative to the company's FDA-approved tiotropium bromide inhalable dry powder, the Spiriva HandiHaler.
The candidate's active ingredient, tiotropium bromide, is the same as that used in the Spiriva HandiHaler, but the Respimat delivers tiotropium bromide as a slow-moving mist via the Respimat Soft Mist Inhaler, Boehringer Ingelheim says.
"We are pleased with the endorsement from PADAC members, and recommendation of approval for tiotropium Respimat in the U.S.," Dr. Sabine Luik, senior vice president of medicine and regulatory affairs, said in a statement. "At Boehringer Ingelheim, we have been committed to discovering and developing new treatments to help people affected by COPD for several decades. If approved, tiotropium Respimat would build upon our heritage in treating respiratory diseases by equipping healthcare providers and their patients with an important new treatment option."
The panel voted unanimously that the candidate is effective in reducing bronchospasm and exacerbations of COPD, and voted 9-4 that the drug has no significant risk of all-cause mortality, according to MedPage Today. Data from the Tiospir trial showing that patients in the mist arm were at a slightly higher risk of cardiac disorder led to the dissent on that question.
The product was rejected in 2007 due to safety concerns and lack of evidence of efficacy. This time around, Boehringer Ingelheim says the Tiospir trial of 17,135 patients shows that the mist formulation is comparable to the Spiriva HandiHaler on both counts. The trial's lead investigator, Dr. Robert Wise of Johns Hopkins University, told the panel that the mist formulation could benefit newly diagnosed patients, those with poor manual dexterity and patients with weak inhalations because they may find it easier to use than the dry-powder counterpart, MedPage Today reports.
The FDA is not obligated to follow the panel's recommendation but usually does so. The mist formulation is already approved in more than 80 countries around the world.
The alternative delivery method is clearly a "cover all of the bases" play given the lack of clinical proof of superior efficacy and safety over the Spiriva HandiHaler. Following now-likely approval, it will be worth inspecting the labeling's details, such as the mist's side effects, to see if they give doctors any additional incentives to choose Spiriva Respimat over the dry-powder formulation of tiotropium bromide for the treatment of COPD.
In July, the FDA approved another Boehringer Ingelheim COPD treatment, the once-a-day inhaler Striverdi Respimat.
- read the release
- here's the MedPage Today article