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Apesar dos obstáculos regulatory, PET as drogas podem dão a imagem latente molecular um impulso

por Olga Deshchenko, DOTmed News Reporter | June 27, 2011
From the June 2011 issue of HealthCare Business News magazine

In the Phase 3 trial, about 150 people volunteered to be imaged. Not all of them died, but the first 35 who did formed the key data set for Amyvid. “We sometimes think of those 35 as pioneers, the individuals who made it possible to get to this point in the field,” Skovronsky says.

So how close is Amyvid to approval? In December, the FDA assigned priority review designation to the drug’s application. Then in January, an FDA advisory panel voted 3-13 against approval because of concerns around reader variability of the scans and a lack of a substantial training framework for clinicians.
But the panel also unanimously voted to approve Amyvid if the company created a rigorous program to train readers.

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“The FDA asked us to establish a reader training program for market interpretation to help ensure reader accuracy and consistency of our scans,” Skovronsky explains. “And they asked us to validate the reader training program using the existing Amyvid scans which were obtained in Phase 2 and Phase 3 of our clinical trials.”

If approved, physicians will be able to use Amyvid to rule out Alzheimer’s disease. But the agent is far from becoming a screening tool.

It’s established that if there is no amyloid in the brain, the patient doesn’t have Alzheimer’s disease. However, the presence of amyloid doesn’t necessarily mean that the patient has the disease. “That is why it’s not a completely accurate diagnostic for Alzheimer's disease but it is a true representation of amyloid in the brain,” says Maria Carrillo, senior director, medical and scientific relations, with the Alzheimer's Association.

“Maybe in the future, there will be definite proof that patients with amyloid in the brain are going to get Alzheimer's, and drugs could be used to remove amyloid out of the brain,” Skovronsky says. “But we’re just not just there yet.”

Nonetheless, the potential approval of Amyvid is generating quite a buzz. This spring, for the first time in 27 years, three expert workgroups published new criteria and guidelines for the diagnosis of Alzheimer's disease. The new guidelines emphasize the importance of biomarkers, such as Amyvid, in the early diagnosis and research into the progression and intervention of Alzheimer's.

Of course, Amyvid will be considered a particularly useful tool in diagnosing Alzheimer's if pharma drugs that can halt the progression of the disease make it to the market. And according to Carrillo, several promising drugs are currently in Phase 3 trials, and many more are in Phase 2.

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