Dosing-Related Economics Arise During FDA Panel’s Arcapta Review
The Pulmonary-Allergy Drugs Advisory Committee’s discussion of Novartis’ Arcapta Neohaler on March 8 briefly veered off in a direction that surely no sponsor wants to see, with panelists debating whether a drug should be dosed less frequently for economic reasons than proposed by the sponsor.
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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.
AMAG outlines plans for retrospective real-world evidence studies, and possibly a new placebo-controlled trial with a primary endpoint of preterm birth <32 weeks, in a filing opposing the Center for Drug Evaluation and Research’s proposal to withdraw the drug.