Lilly's Humalog Backed By FDA Committee

Eli Lilly insulin analog Humalog (insulin lispro) was unanimously recommended for marketing clearance at the US Food and Drug Administration's Endocrine and Metabolic Drug Advisory Committee meeting on February 29. However, the panel also recommended that the drug be available, at least initially, only on prescription.

Since their commercialization in the 1920s, insulin preparations have been commercially available in the USA without a prescription because they are viewed as life-saving drugs. Lilly had hoped to get the same availability for Humalog, but the panel said it would rather see more data from additional trials before it could back non-prescription use. Richard Bergenstal of the International Diabetes Center of Minneapolis and one of Humalog's clinical investigators, noted that "limiting Humalog's availability will leave many people with yesterday's choices - insulin treatment regimens that have improved glycemic control somewhat but failed to completely reproduce the time course of action of the body's own insulin."

Lilly presented evidence to the panel which suggested that Humalog would offer diabetics greater flexibility, allowing them to inject nearer meal times, and provide faster control of blood glucose levels after food intake.