Month: April 2012

Victoza Label Updated to Include Data Showing Superior Efficacy When Compared to Januvia Label update also includes FDA approval of combination therapy with basal insulin for the treatment of adults with type 2 diabetes Adding Levemir (insulin detemir [rDNA origin] injection) to Victoza and metformin in adults with type 2 diabetes PR Newswire PRINCETON, N.J., April 9, 2012 PRINCETON, N.J. , April 9, 2012 /PRNewswire/ — Novo Nordisk received approval from the U.S. Food and Drug Administration (FDA) to update the product label for Victoza (liraglutide [rDNA origin] injection) to include data showing superior blood sugar control when compared to Januvia (sitagliptin). […]

FDA Approves Amyvid™ (Florbetapir F 18 Injection) for Use in Patients Being Evaluated for Alzheimer’s Disease and Other Causes of Cognitive Decline Amyvid is the first and only radioactive diagnostic agent approved for PET imaging of beta-amyloid neuritic plaques in the living brain PR Newswire INDIANAPOLIS, April 6, 2012 INDIANAPOLIS , April 6, 2012 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) and Avid Radiopharmaceuticals, Inc., a wholly owned subsidiary of Lilly, today announced the U.S. Food and Drug Administration (FDA) approval of Amyvid™, a radioactive diagnostic agent indicated for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for Alzheimer’s Disease and other causes of cognitive decline.[1] Amyvid binds to amyloid plaques, a hallmark characteristic of Alzheimer’s Disease,[2],[3],[4] and is detected using PET scan images of the brain.[1] A negative Amyvid scan indicates sparse to no amyloid plaques are currently present, which is inconsistent with a neuropathological diagnosis of Alzheimer’s Disease and reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s Disease.[2] [5] A positive Amyvid scan indicates moderate to frequent amyloid plaques are present; this amount of amyloid plaque is present in patients with Alzheimer’s Disease, but may also be present in patients with other types of neurologic conditions and in older people with normal cognition.[1], [4], [6] It’s important to note that Amyvid is an adjunct to other diagnostic evaluations. A positive Amyvid scan does not establish a diagnosis of Alzheimer’s Disease, or other cognitive disorder. […]