FDA approves Forest Laboratories’ Tudorza Pressair to treat COPD

Jul 24 2012

Forest Laboratories, Inc. (NYSE:FRX) and Almirall, S.A. (ALM.MC) announced today that the U.S. Food and Drug Administration (FDA) has approved Tudorza™ Pressair™ (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.    

COPD is a common, progressive, and debilitating lung disease characterized by persistent airflow limitation that makes it hard to breathe; it is currently the third leading cause of mortality in the US¹. Characteristic symptoms include breathlessness, excessive production of sputum, and a chronic cough.

Tudorza™ is a twice-daily inhaled long-acting anticholinergic, also referred to as a long-acting muscarinic antagonist (LAMA). Tudorza produces bronchodilation by inhibiting acetylcholine's effect on muscarinic receptors in the airway smooth muscle. Forest expects Tudorza Pressair to be available to wholesalers in the fourth calendar quarter of 2012.

"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," commented Howard Solomon, Chairman, Chief Executive Officer, and President of Forest Laboratories commented.

"The FDA approval of Tudorza^TM Pressair^TM 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," commented Jorge Gallardo, President of Almirall.

Professor Richard Casaburi, MD, Associate Chief for Research in the Division of Respiratory and Critical Care Physiology and Medicine, Harbor-UCLA Medical Center, stated, "The Global Initiative for Chronic Obstructive Lung Disease 2011 guidelines recommend long-acting anticholinergics as a first-line therapy for a broad range of COPD patients with moderate to very severe disease. Tudorza will be a valuable anticholinergic option in the clinical armamentarium available to manage this serious disease."