Forest COPD Combo Hits Roadblock En Route To NDA Filing
This article was originally published in The Pink Sheet Daily
Forest is delaying submission of an NDA for aclidinium/formoterol to resolve FDA concerns about the formulation’s chemistry, manufacturing and control specifications.
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News that Forest/Almirall’s LABA/LAMA combination will be delayed due to a manufacturing issue means that GlaxoSmithKline’s Anoro Ellipta will continue to dominate the market as the sole fixed-dose combination available in the U.S.
New drugs are hitting the COPD market, but largely offer incremental benefit over gold standards Advair and Spiriva. Given the modest efficacy improvement and increasingly price sensitive patients and payers, new higher-priced products may find the commercial market a challenge.
The twice-daily aclidinium, a long-acting antimuscarinic agent, should be available to wholesalers in the fourth quarter.