Lilly rDNA Glucagon Is Second Approved, Could Beat Novo GlucaGen Launch
Executive Summary
Lilly's recombinant DNA-derived glucagon is the second approved by FDA and could become the first to reach the market.
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Lilly's recombinant DNA-derived glucagon is the second approved by FDA and could become the first to reach the market. Lilly's version was approved for severe hypoglycemia and for use as a diagnostic aid Sept. 11. Novo Nordisk's GlucaGen cleared FDA June 22. GlucaGen has not been launched pending the signing of a co-marketing agreement. Novo said it is still looking for a partner ("The Pink Sheet" June 29, p. 7). Lilly has not said when it intends to launch its product. Lilly currently markets a glucagon product that is extracted from beef and pork pancreas. As for the other approved glucagon products, Lilly's glucagon for injection is indicated for treatment of severe hypoglycemia in patients with diabetes and as a diagnostic aid in the radiologic examination of the stomach, duodenum, small bowel and colon when diminished intestinal motility would be advantageous. When GlucaGen was approved, Novo noted that use of a rDNA-derived product would eliminate the risk of acquiring bovine spongiform encephalopathy from glucagon therapy. Lilly's glucagon received a "3P" review from FDA, indicating a six-month priority review for a new formulation of an existing product. The NDA (20-928) was originally submitted Dec. 11, 1997, but had a Sept. 12 user fee goal date following a June 8 submission. GlucaGen also received priority review. Novo Nordisk is moving forward in other areas of diabetes treatment. The company filed an NDA for its first insulin analog product Sept. 15. The product, known as NovoRapid (insulin aspart), is a rapid-acting insulin analog for the treatment of diabetes mellitus. Lilly already markets the insulin analog Humalog. Insulin aspart is intended for injection immediately before meals. The rapid action leads to "significantly reduced variability in blood sugar compared to regular human insulin in the period immediately following a meal," the company said. Novo submitted an application for NovoRapid to the European Medicines Evaluation Agency Aug. 12. |