Regulators at the FDA evidently found some problems with a new combo LAMA/LABA COPD therapy in late-stage development by Forest Laboratories ($FRX) and Almirall. The partners say they've decided to put off a New Drug Application for the combination of aclidinium bromide, a long-acting muscarinic antagonist, and formoterol fumarate, a long-acting beta agonist. And the delay could interfere with their plans to compete against rival LAMA/LABA drugs that are further along the approval pathway.
The collaborators had been planning a fourth-quarter application for the treatment, until the FDA offered some unanticipated comments "related to resolving chemistry, manufacturing and control specifications associated with the combination formulation." Typically, these kinds of issues can be resolved in a few months, but the companies didn't offer any details or a new timeline in their release.
Unfortunately for Forest and Almirall, though, there's been a hectic race to develop new LAMA/LABA treatments. And they are well behind some powerhouse players.
Boehringer Ingelheim got a thumbs-up earlier this year from an FDA panel for olodaterol, while Novartis ($NVS) is working on its LAMA/LABA combo QVA149. GlaxoSmithKline ($GSK), allied with Theravance ($THRX), meanwhile, has been pushing for an approval of umeclidinium bromide/vilanterol (UMEC/VI). And AstraZeneca ($AZN) has a late-stage LAMA/LABA project for PT003 after buying Pearl Therapeutics.
In their latest Phase III study, the high dose--400/12 mcg--of the Forest/Almirall combo beat out each individual therapy as well as a placebo when measuring Forced Expiratory Volume (FEV1). But the low (400/6 mcg) dose failed to beat 12 mcg of formoterol at week 24.
"Forest and Almirall are working with the FDA regarding the CMC related comments provided at the pre-NDA meeting to determine the appropriate next steps, and expects to provide an update when more information becomes available," they noted. "The decision to delay the NDA filing for the combination does not affect the Tudorza (aclidinium bromide) monotherapy product," added Forest. The solo drug Tudorza was approved a year ago.
- here's the release