Symlin Approval For Type 1 Diabetes Less Risky Than Potential Off-Label Use, FDA Says
This article was originally published in The Pink Sheet Daily
Off-label use for type 1 diabetes could endanger patients due to higher risk of severe hypoglycemia in type 1 disease if pramlintide were approved only for type 2 diabetes, FDA review documents show. Lengthy NDA review illustrates difficulty of designing trials in the context of insulin use, where benefit is tied to risk.
You may also be interested in...
Agency evaluation follows a medication safety alert for the adjunctive diabetes therapy issued by the Institute for Safe Medication Practices. Watchdog group cites confusion in dosage instructions that could result in overdose/underdose of Symlin.
The approval follows the company’s submission of a re-analysis of hypoglycemia data in response to an FDA “approvable” letter. The product is approved as an adjunct treatment for Type 1 and 2 diabetes.
Immuno-Oncology’s ‘Infancy’? ‘Adolescence?’ Wherever You Peg Development, Adverse Event Reporting Needs To Mature
A common toxicity of advanced IO therapies, cytokine release syndrome needs to be better characterized as part of the groundwork for future development of the field, according to Friends of Cancer Research.