Clinical Trials Or Observational Studies For Asthma? FDA Advisory Panels Can't Agree
Whether randomized controlled clinical trials or observational studies are best for measuring the risks of long acting beta-2 adrenergic agonists remains unresolved after a two-day FDA advisory committee meeting
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FDA says Novartis’ assessment of the long-acting beta agonist’s REMS, which consisted only of a communication plan, shows the “plan, and therefore the REMS, has met its goal.”
The trials, which follow a label change and new REMS, will encompass seven times the patients included in the studies submitted to FDA for approval.
FDA’s lingering concerns about the appropriate dose for Novartis’ chronic obstructive pulmonary disease therapy Arcapta Neohaler (indacaterol) suggest the agency will take a harder line on dosing data requirements for new COPD treatments, particularly when they have not first been approved in asthma.