• FDA Releases Guidance Document on Alzheimer's Disease

    • 07 February 2013
    A new draft guidance document released by the US Food and Drug Administration (FDA) seeks to provide sponsors with a better understanding of how it intends to regulate drug products that treat a disease that manufacturers and patients alike have long sought better treatments for: Alzheimer's disease (AD). Background The guidance, Alzheimer's Disease: Developing Drugs for the Treatment of Early Stage Disease , was released on 7 February 2013. FDA explained that eve...
  • Warning Letter to Eli Lilly Focuses on Use of Color Images in Marketing Materials

    The US Food and Drug Administration (FDA) has sent a warning letter to pharmaceutical manufacturer Eli Lilly over alleged deficiencies present in marketing materials distributed by the company through its website, FDA announced on 10 September. The letter, posted on FDA's website by the Office of Prescription Drug Promotion (OPDP), references marketing materials published for Amyvid (Florbetapir F 18 Injection), a positron emission tomography (PET) drug used to help eval...
  • Group Sues FDA, Seeking to Compel it to Withdraw Alzheimer's Drug from Market

    Consumer advocacy group Public Citizen has filed a lawsuit against the US Food and Drug Administration (FDA) seeking to compel it to remove a particular dose of the Alzheimer's drug Aricept, which the group alleges is causing dangerous and potentially fatal side effects. The lawsuit stems from a May 2011 Citizen's Petition filed by the group. The letter, addressed to FDA Commissioner Margaret Hamburg, calls for the 23 mg dose of Eisai's drug Aricept to be removed bec...
  • Eli Lilly Gets Approval for Brain Plaque Test

    • 09 April 2012
    The US Food and Drug Administration (FDA) has approved a test that would help doctors detect brain plaque to rule out Alzheimer's disease in patients, according to a Reuters report. The radioactive dye, called Amyvid, attaches to clumps of beta amyloid, a toxic protein accumulating in the brains of Alzheimer's patients. The report said doctors can see the plaque light up due to the dye on a positron emission tomography (PET) scan. Eli Lilly and Co. said the test should ...
  • Europe: European Medicines Agency Adopts Two Alzheimers Biomarkers

    Under a voluntary new scientific pathway, the European Medicines Agency (EMA) adopted two innovative biomarkers for use in the development of new medications for Alzheimers submitted by Bristol-Myers Squibb: PET amyloid imaging (positive/ negative) as a biomarker for enrichment for use in predementia AD clinical trials , and use of CSF AB 1-42 and t-tau and/or PET-amyloid imaging (positive/ negative) . The new process can lead to either a Committee for Medicinal Produ...
  • BMJ: Despite Warning, FDA Approved Higher-Dose Aricept

    An article in The British Medical Journal ( BMJ) claims the US Food and Drug Administration (FDA) approved a higher-dose version of Eisai's blockbuster Alzheimer's drug Aricept 23 (donepezil) despite the concerns of its reviewers at FDA, reports The New York Times . FDA review staff noted their concerns about the drug's safety and efficacy, according to  The Times, finding little evidence of the drug's effectiveness in a 1,400-person clinical trial, but finding...