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.
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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.
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