Amylin Symlin Complete Response Follows “Emerging Consensus” On Hypoglycemia
This article was originally published in The Pink Sheet Daily
Response to second “approvable” letter includes re-analysis of hypoglycemia data showing lower rates of medically-assisted hypoglycemia in type 1 and 2 diabetes patients compared to overall rates in pivotal studies, Amylin says.
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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.
The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.