هيئة الغذاء و الدواء ترفض عقار الشيزوفرينيا لشركة ليلي-أميفيد

FDA advisors say ‘no’ to Lilly’s Amyvid

The progress of Eli Lilly’s Amyvid has suffered a setback in the US after regulatory advisers voted not to recommend the Alzheimer’s disease imaging agent for marketing approval.

Amyvid (florbetapir) is a molecular imaging tool under investigation for the detection of beta-amyloid plaque – the presence of which is associated with Alzheimer’s disease – which Lilly acquired through its purchase of Avid Radiopharmaceuticals in December last year.

But while the US Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee voted (13-3) not to recommend approval of Amyvid (florbetapir) at this time, it did vote unanimously that it would put forward the agent for marketing clearance if Lilly develop a training program to ensure accuracy and consistency in the way the brain scans are interpreted.

And on the plus side, the Committee agreed that Amyvid’s efficacy was established and that a negative scan would be clinically useful in indicating that Alzheimer’s pathology is unlikely to be the cause of a patient’s cognitive decline. In addition, no significant safety concerns raised.

Despite the current rejection, Daniel Skovronsky, chief executive of Avid Radiopharmaceuticals, said he is “encouraged” that the Committee “recommended a clear path toward approval” for the agent.

FDA advisors say ‘no’ to Lilly’s Amyvid