COPD Market Snapshot: New Products, Limited Differentiation
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.
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At the American Thoracic Society annual meeting, science committee chair says change in COPD treatment guidelines to favor LABA/LAMA as preferred option will be considered soon.
Sponsor’s claimed impact on exercise tolerance was not adequately supported and should not serve as a marketing advantage for the chronic obstructive pulmonary disease drug, FDA review staff said. However, Boehringer Ingelheim’s failed attempt for the exercise-related labeling language spurred the agency to clarify the types of studies and endpoints that potentially could support such claims.
The long-acting beta agonist olodaterol cleared FDA for treatment of chronic obstructive pulmonary disease, but it didn’t gain the differentiating claim the German pharma was seeking.