April 18, 2019
The FDA has approved Duaklir Pressair (aclidinium bromide and formoterol fumarate; Circassia Pharmaceuticals) for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).
The treatment is a fixed-dose LAMA/LABA combination and should be administered twice daily by using the pre-loaded, multi-dose inhaler.
The approval was based on data from several studies that include ACLIFORM, AUGMENT, and AMPLIFY. According to findings from the AMPLIFY clinical trial, Duaklir Pressair improved lung function versus aclidinium as measured by the change from baseline at 24-weeks in the forced expiratory volume in one second (FEV1) one-hour post-dose. Further, the treatment also increased lung function versus formoterol measured by change from baseline in pre-dose morning (trough) FEV1 at week 24. Finally, symptoms that were observed at both nighttime and early morning via severity scores showed numerical improvements with the newly approved treatment compared to both aclidinium or formoterol over 24 weeks.
The most commonly reported adverse events, which were similar between treatment groups in the AMPLIFY trial, included:
- COPD exacerbations (18.3%);
- nasopharyngitis (11.8%); and,
- headache (4.9%).
Based on the trial findings, the incidence of serious adverse events was 7.8%. Serious adverse events included major adverse cardiovascular events (0.7%), as well as adverse events that lead to discontinuation (7.1%) or death (0.5%). Overall, serious adverse events were low in AMPLIFY and similar across treatment groups.
“The FDA approval of DUAKLIR PRESSAIR gives COPD patients a new, effective and safe option in LAMA/LABA therapy, enabling them to receive maximal improvement in lung function delivered through a unique dry-powder inhaler,” Michael Asmus, vice president of US Medical Affairs at Circassia, said in a statement.