F.D.A. Sees Promise in Alzheimer’s Imaging Drug

By GINA KOLATA, Published: January 20, 2011
An advisory committee to the Food and Drug Administration recommended unanimously Thursday that the agency approve the first test — a brain scan — that can show the characteristic plaques of Alzheimer’s disease in the brain of a living person. The approval was contingent on radiologists agreeing on what the scans say and doctors being trained in how to read the scans.

The F.D.A. usually follows advice from its advisory committees, and Alzheimer’s experts anticipated that the scans would be approved. The additional requirement would not be a big hurdle, said Dr. Daniel M. Skovronsky, chief executive of the company, Avid Radiopharmaceuticals, that applied to market the scans.

“We don’t know exactly what F.D.A. will want,” Dr. Skovronsky said. “But it should take months to generate this type of data, not years.”

The committee vote is “a very positive thing,” said Maria Carrillo, senior director of medical and scientific relations for the Alzheimer’s Association. “This is nothing but a positive for our families.”

More than five million Americans have Alzheimer’s disease.

Plaques are part of the criteria for having Alzheimer’s — if a person with memory problems does not have plaques, that person does not have Alzheimer’s. But without the scan, the only way to know if plaques were present is to do an autopsy.

Alzheimer’s specialists said they expected that if the scan were approved it would come into widespread use.

“This is a big deal,” said Dr. Pierre N. Tariot, director of the memory disorders center at the Banner Alzheimer’s Institute in Phoenix. Asked if he would be using the scans, Dr. Tariot replied, “Absolutely.” Read more at the NY Times Read More...

Tags: Food and Drug Administration, Gina Kolata, Daniel M. Skovronsky, Maria Corrillo, Avid Radiopharmaceuticals, Banner Alzheimer’s Institute, Dr. Pierre N. Tariot, Alzheimer's Associaton