FDA panels back Forest and Almirall COPD drug and Chelsea's Northera for NOH

The US Food and Drug Administration’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 12 to two in favor of approving the New Drug Application for aclidinium bromide, a new long-acting antimuscarinic for the maintenance treatment of chronic obstructive pulmonary disease (COPD0, under development by the USA’s Forest Laboratories (NYSE: FRX) and originator Almirall (ALM: MC), Spain’s largest drugmaker.

The Committee was also asked to separately evaluate if the efficacy and safety of the 400mcg twice daily dose had been adequately demonstrated. The members voted unanimously in favor of efficacy and 10 to three (one member abstained) in favor of safety. However, panellists noted that patients taking the highest dose of the drug may have increased heart risks, and additional studies are needed to confirm its long-term safety. Most panel members called for a comprehensive registry or a one-to two-year study to ensure there aren’t rare, serious side effects stemming from the use of aclidinium bromide, according to Bloomberg.

Yesterday’s committee recommendations, although not binding, will be considered by the FDA as it completes its review of the NDA for aclidinium bromide. Forest and Almirall anticipate receiving FDA feedback on the filing in the second quarter of this year. If approved, Forest has proposed marketing the drug under the brand name Tudorza Pressair.