The US Food and Drug Administration (FDA) will have to wait to get its hands on Forest Laboratories and Almirall’s combination respiratory drug after the companies delayed its regulatory submission.
The two pharma firms had intended to submit the combination of aclidinium bromide and formoterol fumarate in chronic obstructive pulmonary disorder (COPD) by the end of 2013, but comments from the FDA ahead of the New Drug Application (NDA) have put these plans on hold.
“The delay is related to resolving chemistry, manufacturing and control (CMC) specifications associated with the combination formulation,” said Forest.
Both Forest and Almirall are now working with the FDA regarding these specifications, although gave no potential date for future submission.
The drug is a combination of Forest’s long-acting muscarinic antagonist (LAMA) Tudorza (aclidinium bromide) and Astellas’ long-acting beta agonist (LABA) formoterol fumarate.
These LAMA/ LABA combinations provide a convenient advance for COPD patients over the monotherapy versions, and are of increasing interest for pharma companies.
GlaxoSmithKline (GSK) and Theravance were the first to submit a drug in this area with Anoro – a combination of umeclidinium bromide and vilanterol – while the likes of Boehringer Ingelheim and Novartis are also developing LAMA/ LABA combinations.
The delay is a blow to Forest and Almirall’s plans in the field and could let their rivals steal a march.
This is despite positive phase III results from clinical results, which demonstrated statically significant improvements for patients taking the combination drug versus placebo.