NEW YORK—Forest Laboratories, Inc. and Almirall, S.A. haveannounced that they have received U.S. Food and Drug Administration (FDA)approval for Tudorza Pressair (aclidinium bromide inhalation powder) under theindication of long-term maintenance treatment of bronchospasm associated withchronic obstructive pulmonary disease (COPD), including chronic bronchitis andemphysema. The drug is a twice daily, inhaled long-acting anticholinergic, alsoknown as a long-acting muscarinic antagonist. Tudorza Pressair promotesbronchodilation by the inhibition of acetylcholine's effects on muscarinicreceptors found in the airway smooth muscle. Forest Laboratories expects theproduct to be available to wholesalers by the fourth quarter of this year.
"We are pleased with the FDA approval of Tudorza. Asthe first long-acting inhaled anticholinergic agent approved in over eightyears for COPD, Tudorza will be an important treatment option available for themillions 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 partnershipwith Almirall and advances Forest's respiratory franchise and our commitment toCOPD patients."
COPD is a progressive and debilitating lung disease markedby chronic airflow limitation, with symptoms that include breathlessness,excessive sputum production and chronic cough. The disease currently ranks as afactor of the third leading cause of death in the United States, according tothe Centers for Disease Control and Prevention, who recorded 137,252 deaths in2009 attributable to chronic lower respiratory diseases. In all three trials of Tudorza, the drug showedstatistically significant improvements in bronchodilation when compared toparticipants taking the placebo. In addition, the drug demonstrated a lowincidence 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 thatdelivers 60 doses of the drug.
Forest Laboratories licensed U.S. rights for aclidinium fromAlmirall in 2005, with Kyorin Pharmaceutical Co., Ltd. holding marketing rightsin Japan and Daewoong Pharmaceutical Co., Ltd. holding marketing rights inKorea. Almirall has also recently granted rights of joint commercialization inthe majority of European member states and select non-European Union countriesto Menarini, while itself retaining rights for the rest of the world.
"The FDA approval of Tudorza Pressair demonstrates oursteadfast commitment to the development of respiratory compounds, such asaclidinium, innovative delivery devices and our unfailing belief in theirpotential for the treatment of COPD," Jorge Gallardo, president of Almirall,said in a press release. "Today, we celebrate this achievement for our companyand, most importantly, for the patients we serve."
"The Global Initiative for Chronic Obstructive LungDisease 2011 guidelines recommend long-acting anticholinergics as a first-linetherapy for a broad range of COPD patients with moderate to very severedisease. Tudorza will be a valuable anticholinergic option in the clinicalarmamentarium available to manage this serious disease," Prof. RichardCasaburi, M.D., associate chief for research in the division of Respiratory andCritical Care Physiology and Medicine at Harbor-UCLA Medical Center, said in apress release.
SOURCE: Forest Laboratories, Inc.
