FDA Requests More Data On Forest Lab's COPD Drug Combo

Forest Laboratories and partner Almirall S.A. announced that the U.S. Food and Drug Administration (FDA) has issued a request for more information regarding questions related to Chemistry, Manufacturing, and Control (CMC) of its fixed dose combination of aclidinium and formoterol. The companies said that a Type C meeting with the FDA is going to be set in line with the request.

Aclidinium bromide /formoterol fumarate is an investigational fixed dose combination for the treatment of chronic obstructive pulmonary disease (COPD). Both are approved long-acting bronchodilators with different mechanisms of action and similar pharmocodynamic profiles. Aclidinium bromide is an anticholinergic or long-acting muscarinic antagonist (LAMA) that induces bronchodilation by inhibiting the muscarinic M3 receptor in the airway smooth muscle. Formoterol fumarate is a long-acting beta-agonist (LABA) that works to stimulate B2-receptors in the bronchial smooth muscle leading to bronchodilation. Both aclidinium bromide (Tudorza®/ Eklira®) and formoterol fumarate have received approval for the maintenance treatment of COPD in U.S. and Europe.

Almirall and Forest have conducted two pivotal Phase III clinical trials for aclidinium/formoterol in 2013. The treatment combination was administered twice a day to patients in the trial, which met its primary endpoints. The trial demonstrated statistically significant improvements compared to placebo. The combination was well tolerated in both studies.

Meetings with the FDA under Guidance for Industry category are classified by priority as Type A, B, or C. Type A meeting is indicated for resolution of disputes, clinical holds, or special protocols. Type B includes pre-IND meetings, end of Phase1/2/pre-Phase 3 meetings, and others. Type C meetings cover any other concerns not specified in the first two types.

The company said no new issues regarding its COPD drug have been raised so far. “Forest and Almirall believe that the fixed dose combination of aclidinium and formoterol can be an important therapy for U.S. COPD (Chronic Obstructive Pulmonary Disease) patients,” the companies stated in the press release.