B-I Receives Two Approval Recommendations In USA

Boehringer Ingelheim has gained a recommended approval from the US Food and Drug Administration's Pulmonary-Allergy Drugs advisory committee for both its Combivent (ipratropium bromide/albuterol sulfate) and Atrovent (ipratropium) products for the treatment of chronic obstructive pulmonary disease for those patients who are felt to require a second aerosol bronchodilator, and rhinorrhea associated with perennial rhinitis, respectively.

Regarding the recommendation for Combivent, the committee reviewed efficacy data from two pivotal studies involving over 1,000 patients. Over the duration of the studies, the Combivent arm showed a higher level of mean forced expiratory volume area under the curve over six hours compared to ipratropium and albuterol alone.

Safety data for the product was deemed to be adequate, said the committee. However, Babatunde Otulana, an FDA medical reviewer for the pulmonary division, said that there was some concern based on spontaneous adverse event reports that the drugs used in combination might result in some ocular complications in susceptible patients.