Aclidinium and formoterol fixed dose combo for COPD filed in Europe by Almirall

Spain’s largest drugmaker Almirall (ALM: MC) has filed a Marketing Authorization Application to the European Medicines Agency for the fixed combination of aclidinium bromide (LAMA) and formoterol fumarate (LABA - long-acting beta2 agonist) for the treatment of chronic obstructive pulmonary disease (COPD).

The regulatory submission is based on efficacy and safety data from two pivotal Phase III studies (ACLIFORM/COPD and AUGMENT/COPD) - run in 25 countries worldwide - which were completed this year. Additional long-term safety studies (LAC-MD-32 and LAC-MD-36) complete a robust safety clinical data package including more than 4,000 patients in the program, said Almirall.

“The success of this Phase III program supports the potential of aclidinium/formoterol as a new treatment option for COPD patients who could benefit from the enhanced bronchodilation of two complementary, proven therapies,” said Alvar Agusti, a professor and director of the Institut Clínic del Torax, Hospital Clinic, Universitat de Barcelona, Spain. “The reliable bronchodilation and symptoms’ improvements during the day and at night demonstrated by the combination provide a new highly efficacious and safe treatment option,” he added.