The u.s. Food and Drug Administration has approved a drug for Alzheimer's disease on Monday, for the first time, the agency has confirmed a new treatment for the disease since 2003. This comes after, in November, an independent consulting group that called on the agency to give up the drug, called aducanumab, is warning that the treatment showed a slow progression of the disease.
Aducanumab is the only medicine is considered by the fda is likely to cure the underlying condition, rather than deal with so many of the symptoms of anxiety and insomnia. It is made by the Massachusetts - based company, the Market, and will be marketed under the Aduhelm name.
This decision could affect millions of older Americans and their families, and will, no doubt, to be the cause of much controversy in the medical community, medical researchers, and patients. It also has a far-reaching result of the use of standards for the assessment, including the experimental methods and techniques for processing in order to display the additional benefits.
Maria Carrillo, chief science officer at the Alzheimer's Association, hailed the announcement as a "historic moment in the history of the area."
"The Alzheimer's Association believes that this will open up a new era in Alzheimer's disease treatment and research," he said. "For people living with Alzheimer's, a disease, treat, this means the potential to prevent a fall."
The u.s. Food and Drug Administration, recognized both the existence of the controversy surrounding it are medicine, in a statement issued by the Dr. A Cavazzoni, executive director of the Center for Drug Evaluation and Research, u.s. Food and Drug Administration.
"It was an important public debate about whether or not Adukhelm to be accepted. As is often the case when it comes to interpreting scientific information and expert community, offering a different point of view," he wrote, adding that "the information contained in the applicant's submission was a very difficult one, and kept the remaining uncertainties related to clinical benefit."
During a media briefing on Monday, Cavazzoni, explained that the drug was approved in the fast-track FDA-approved method is a method that allows the FDA-approved medications, in the event of serious or life-threatening conditions after they left, "has been shown to increase in a kind of end point, which was considered to be reasonable, are likely to predict clinical blessing."
In this case, the Aduchelm is a surrogate end-point was a reduction in brain amyloid-cells, is a protein that is considered to be a sign of disease. However, in this board you predict the clinical benefit of the drug with a sufficient degree of probability," he said.
However, indicating that the treatment is reasonably likely to predict clinical benefit, does not mean that it will guarantee that it will. This drug has been approved in a timely manner by the FDA, and should continue to be learning medicine, in its confirmation of clinical benefit.