Issue 177 Item 5 Novo Gets FDA “Approvable Letter” For Detemir Insulin

Novo Nordisk said on Wednesday it received an “approvable letter” from U.S. regulators for its new insulin product but analysts said it remains uncertain when the Danish firm will start selling the product.

Novo previously said it planned a mid-2004 launch of the long-acting insulin, known as detemir, for the treatment of diabetes, but the company gave no details on the timing in its latest statement.

The U.S. Food and Drug Administration (FDA) typically gives approvable letters when it is broadly satisfied with a new medicine, but requires detailed information.

"In the letter, the FDA requests that Novo Nordisk addresses certain clinical issues and provides additional information before U.S. marketing approval can be granted," the company said.

"It’s a milestone on the way to final approval. It would have been remarkable if detemir had been approved so quickly," said Mike Rulis, Novo’s head of communications. Novo, the world leader in diabetes care, filed the application for approval by FDA in December.

Novo Nordisk is working with the agency to clarify and resolve outstanding issues and said it would give more information on how the process was going in its third-quarter report on October 29.

Industry analysts said the rollout of the new insulin is critical to Novo since Franco-German Aventis SA currently has the only long-acting insulin product (Lantus) on the market.

In August, Novo said detemir had shown important benefits over existing products, including Lantus.

However, analysts are wary, since detemir will have to be given twice daily to some patients, while Lantus has a more convenient once-daily formulation for all.