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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Lilly/Amylin Byetta clears FDA as first incretin mimetic; GSK readies Boostrix launch following May 3 BLA approval. GlaxoSmithKline’s dopamine agonist Requip (ropinirole) is approved May 4 as the first treatment for restless legs syndrome. More FDA approvals in brief

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Long-acting exenatide data

Lilly and Amylin announce data Aug. 22 from a 45-patient Phase II study of a long-acting release (LAR) formulation of the incretin mimetic Byetta (exenatide) in type 2 diabetes using Alkermes' Medisorb injectable extended-release delivery technology. Patients in the 15-week study were randomized to one of two once-weekly doses of exenatide LAR or placebo. HbA1C "improved approximately 2% for subjects receiving the high dose of exenatide LAR compared to placebo," Amylin says; baseline A1C in the study was 8.5%. Fasting blood glucose concentrations decreased approximately 50 mg/dL in the high dose group vs. placebo, the firm reports. FDA approved immediate-release Byetta on April 28 for twice-daily dosing (1Pharmaceutical Approvals Monthly May 2005, p. 20)...

Long-acting exenatide data

Lilly and Amylin announce data Aug. 22 from a 45-patient Phase II study of a long-acting release (LAR) formulation of the incretin mimetic Byetta (exenatide) in type 2 diabetes using Alkermes' Medisorb injectable extended-release delivery technology. Patients in the 15-week study were randomized to one of two once-weekly doses of exenatide LAR or placebo. HbA1C "improved approximately 2% for subjects receiving the high dose of exenatide LAR compared to placebo," Amylin says; baseline A1C in the study was 8.5%. Fasting blood glucose concentrations decreased approximately 50 mg/dL in the high dose group vs. placebo, the firm reports. FDA approved immediate-release Byetta on April 28 for twice-daily dosing (1Pharmaceutical Approvals Monthly May 2005, p. 20)...

Lilly/Amylin submit exenatide

Lilly/Amylin plan to position their type 2 diabetes agent exenatide for use in patients not achieving goal on oral agents; an NDA for the first-in-class incretin mimetic was submitted June 30. "The initial target population for exenatide does not include patients on insulin," Lilly says. Based on exenatide's novel mechanism, the firms are highlighting its potential as an insulin alternative "that carries a lower risk of hypoglycemia with no weight gain." A National Institutes of Health-sponsored study of exenatide in type 1 diabetes is underway. "The results of that [20-month] exploratory study will determine our next steps in the type 1 diabetes arena," Lilly says...

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