Symlin approvable, more data wanted

AMLN received an approvable letter from the FDA for its Symlin pramlintide to treat Type I and Type II diabetes, although the company said approval will require additional clinical work. AMLN said it plans to meet with the FDA to discuss specific clinical requirements. Symlin is an analog of human amylin, a hormone secreted with insulin by the beta cells in the pancreas.

In July, the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 8-1 and 6-3 against approval of Symlin to treat Type I and Type II diabetes, respectively (see BioCentury, July 30). The panel did vote 8-1 that the company's data showed the product has efficacy and reduced HbA1c levels in both Type I and Type II patients, but members expressed concern about the relatively high incidence of hypoglycemia that occurred during the first 4 weeks of therapy. The panel recommended that AMLN run a double-blind trial titrating dosages of insulin and use a reduced dose of Symlin during initiation of therapy in Type I and possibly also Type II patients. The product also is under review in Europe. AMLN was up $1.27 (17%) to $8.59 on Friday. ...