Login Signup Home Sitemap Contact us

Home > BBS > Announcement
미국 식약청에서 Florbetapir (Amyvid)를 승인한 기사
2012-04-12 2093

For Immediate Release: April 10, 2012
Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA approves imaging drug Amyvid
Estimates brain amyloid plaque content in patients with cognitive decline

The U.S. Food and Drug Administration today approved Amyvid (Florbetapir F 18 Injection) a drug for Positron Emission Tomography (PET) imaging of the brain in adults who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. Cognitive decline refers to a condition where the ability to think and form clear, rational thoughts and decisions has decreased. It can cause an individual to lose touch with reality, oneself, other people, and external events and surroundings.

Amyvid is used to produce PET scans that estimate the brain β-amyloid neuritic plaque density in patients with cognitive impairment.  β-amyloid protein is a type of protein that forms in patients with AD and some other cognitive disorders. Neuritic plaques, also called amyloid plaques, are abnormal clumps of brain cells mixed with β-amyloid protein. A negative Amyvid scan indicates few to no neuritic plaques and reduces the likelihood that any cognitive impairment is due to AD.  A positive scan indicates moderate to frequent plaques. This amount of β-amyloid plaque can be found in patients with AD, in patients with other types of cognitive impairment, and in older people with normal cognition.

“Many Americans undergo evaluations to try to determine the cause for a decline in cognitive functioning,” says Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research.  “Until now, the brain content of β-amyloid neuritic plaques could only be determined with a brain biopsy or examination of the brain at autopsy.  This imaging agent is one tool to help physicians in the assessment of their patients by serving as an adjunct to other diagnostic evaluations.”

Following intravenous injection, Amyvid (a radioactive drug) binds to brain β-amyloid.  A radioactive signal is detected with a PET scanner to produce images of the plaque in the brain. A positive Amyvid scan indicates moderate to frequent plaques.  However, a positive Amyvid scan does not establish a diagnosis of AD because, although patients with AD always have an increased brain content of plaque, the test also may be positive in patients with other types of neurologic conditions, as well as in older people with normal cognition.

Amyvid is not a test for predicting the development of AD-associated dementia and is not for monitoring patient responses to AD therapy.  Amyvid does not replace other diagnostic tests used in the evaluation of cognitive impairment. This is a new type of nuclear medicine test and images should be interpreted only by healthcare professionals who successfully complete a special training program developed by the manufacturer.  The Amyvid label includes information on interpretation of Amyvid PET images.

Common adverse reactions include headache, musculoskeletal pain, fatigue, and nausea.  Safety risks include radiation risk and risks associated with image misinterpretation.

Amyvid is manufactured for Avid Radiopharmaceuticals in Philadelphia.

게시물 101건
No. Subject File Name Date Hit
89   The 14th KAST International Symposium on Nuclear M… 관리자 04-30 1897
88   홈커밍데이 공지 (6월 2일 토요일 1:30) 이병세 04-19 1884
  미국 식약청에서 Florbetapir (Amyvid)를 승인한 기사 지대윤 04-12 2094
85   제 5차 방사성의약품 화학연구회 개최 안내 관리자 01-05 2043
84   제 34회 “헤테로고리 화합물의 화학”심포지엄 안내 관리자 02-28 2383
83   109차 대한화학회 안내 관리자 02-13 1773
82   2012년 신년하례식 공지 관리자 12-21 1909
80   2011 한국원자력의학원 핵의학 심포지움 관리자 11-22 2158
79   2011년도 한국유기합성학회 정기총회 및 학술대회 관리자 11-22 3211
78   Albatross Fellowship (알바트로스 펠로우십) 관리자 11-10 2022
77   2011년 분자영상학회 추계학술대회 관리자 11-03 2229
76   대한핵의학회 50주년 기념 추계학술대회 초록 제출 안… 관리자 09-07 2097
75   대한화학회 제108회 총회 및 학술발표회 초록 등록 안… 관리자 09-07 2082
74   제 33회“헤테로고리화합물의화학”심포지엄안내 관리자 09-07 2223
73   Magic SN2 ionic liquid - Good example 관리자 07-12 2637
[1][2] 3 [4][5][6][7]