Six Years And Four Trials Later, LABA/ICS Combos Twist Free Of Box Warning
US FDA concludes that combination products do not increase risk of serious asthma-related events compared to inhaled corticosteroids alone.
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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.
On top of a class-wide Risk Evaluation and Mitigation Strategy for the long acting beta-2 adrenergic agonist class of asthma drugs, FDA is going to work through its Safe Use partners to monitor whether actual use adjusts based on the new safety measures
The FDA commissioner also does not want the agency setting goals for rare disease treatment development.