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Forest, Almirall get green light for COPD treatment
NEW YORK—Forest Laboratories, Inc. and Almirall, S.A. have announced that they have received U.S. Food and Drug Administration (FDA) approval for Tudorza Pressair (aclidinium bromide inhalation powder) under the indication of long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. The drug is a twice daily, inhaled long-acting anticholinergic, also known as a long-acting muscarinic antagonist. Tudorza Pressair promotes bronchodilation by the inhibition of acetylcholine's effects on muscarinic receptors found in the airway smooth muscle. Forest Laboratories expects the product to be available to wholesalers by the fourth quarter of this year.
"We are pleased with the FDA approval of Tudorza. As the first long-acting inhaled anticholinergic agent approved in over eight years for COPD, Tudorza will be an important treatment option available for the millions of patients living with this serious disease," Howard Solomon, chairman, president and CEO of Forest Laboratories, said in a press release. "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."
COPD is a progressive and debilitating lung disease marked by chronic airflow limitation, with symptoms that include breathlessness, excessive sputum production and chronic cough. The disease currently ranks as a factor of the third leading cause of death in the United States, according to the Centers for Disease Control and Prevention, who recorded 137,252 deaths in 2009 attributable to chronic lower respiratory diseases.
In all three trials of Tudorza, the drug showed statistically significant improvements in bronchodilation when compared to participants taking the placebo. In addition, the drug demonstrated a low incidence of side effects, with the most common being headache, nasopharyngitis (inflammation of the nasal passages as well as the upper pharynx) and cough. Tudorza is administered via Pressair, a multiple-dose dry powder inhaler that delivers 60 doses of the drug.
Forest Laboratories licensed U.S. rights for aclidinium from Almirall in 2005, with Kyorin Pharmaceutical Co., Ltd. holding marketing rights in Japan and Daewoong Pharmaceutical Co., Ltd. holding marketing rights in Korea. Almirall has also recently granted rights of joint commercialization in the majority of European member states and select non-European Union countries to Menarini, while itself retaining rights for the rest of the world.
"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," Jorge Gallardo, president of Almirall, said in a press release. "Today, we celebrate this achievement for our company and, most importantly, for the patients we serve."
"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," Prof. Richard Casaburi, M.D., associate chief for research in the division of Respiratory and Critical Care Physiology and Medicine at Harbor-UCLA Medical Center, said in a press release.
SOURCE: Forest Laboratories, Inc.