Advisory Panel Urges FDA To Approve Amgen Drug, Nplate

Boston (dbTechno) - A U.S. advisory panel to the FDA has urged that regulators approve a new drug from Amgen Inc to treat a rare blood disorder, even though it puts patients at risk of adverse effects, including serious bleeding. The drug is called Nplate.

The Food and Drug Administration has been contemplating and waiting for ideas from this panel to decide whether or not to approve Nplate.

The panel has been weighing whether or not the risks of the drug outweigh the benefits of it.

The vote was unanimously in favor of Nplate.

It is a drug which treats a rare blood disorder called chronic immune thrombocytopenia purpura. This disorder causes brusing and bleeding following just minor injuries. It affects 200,000 people in the U.S.

Amgen has stated that if the drug was approved, it would not commercially market the drug to patients. It would limit the distribution of it and watch the side effects of it.

This is due to the worrying side effects, such as the risk of serious bleeding in patients.

Many raised concerns prior to this panel vote that the risks of the drug were too high, and that the benefit was not enough to look past the potential harm it could put patients of it through.

Amgen is expecting a final ruling shortly from the FDA, likely before June 2008.

The FDA historically follows the advice of the panels, meaning it is more than likely that Nplate will now be approved.