The FDA has approved the Tudorza Pressair aclidinium bromide dry powder inhaler for the treatment of COPD. The DPI will be distributed by Forest Pharmaceuticals, a division of Forest Laboratories, which licensed US rights to the product from Almirall. Forest says that it expects wholesalers to have the product in the fourth quarter of 2012.
Almirall President Jorge Gallardo commented, “The FDA approval of Tudorza Pressair demonstrates our steadfast commitment to the development of respiratory compounds, such as aclidinium, innovative delivery devices, and our unfailing belief in their potential for the treatment of COPD. Today, we celebrate this achievement for our company and, most importantly, for the patients we serve.”
“We are pleased with the FDA approval of Tudorza. As the first long-acting inhaled anticholinergic agent approved in over 8 years for COPD, Tudorza will be an important treatment option available for the millions of patients living with this serious disease. Tudorza’s approval marks an important milestone in our ongoing partnership with Almirall and advances Forest’s respiratory franchise and our commitment to COPD patients,” said Forest Laboratories Chairman, CEO and President Howard Solomon.
FDA Director of the Office of Drug Evaluation II in FDA’s Center for Drug Evaluation and Research (CDER) Curtis Rosebraugh noted, “COPD is a serious disease that gets worse over time. The availability of long-term maintenance drugs for COPD provides additional treatment options for the millions of people who suffer with this debilitating disease.”
The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted in favor of approval of the NDA in February 2012. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has also recommended approval in Europe, where it would be marketed as the Eklira Genuair.
Read the Forest and Almirall press release.
Read the FDA press release.
