Acusphere Future Up In Air After Imagify Fails Before Advisory Panel
Executive Summary
Evolving trial design standards and miscommunication with the review division tripped up Acusphere's effort to bring Imagify to market, signaling to competitors in the space that FDA is raising the bar on contrast imaging agents
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Imagify gets “complete response”
An FDA "complete response" letter for Acusphere's Imagify suggests that additional clinical work will be required to support its proposed use as a screening tool to stratify patients for referral to coronary arteriography, the firm announces March 11. The company says the letter is largely consistent with the feedback it received from an FDA advisory committee in December; the panel voted 16-1 with one abstention against Imagify approval due to evolving trial design standards, miscommunication with the FDA review division, inconsistent efficacy, safety signals and unconvincing diagnostic value (1"The Pink Sheet," Dec. 15, 2008, p. 17). Acusphere submitted a narrower claim for the imaging agent in February with a potentially improved risk-benefit ratio, and is in the process of scheduling a meeting with FDA to discuss alternatives
Imagify gets “complete response”
An FDA "complete response" letter for Acusphere's Imagify suggests that additional clinical work will be required to support its proposed use as a screening tool to stratify patients for referral to coronary arteriography, the firm announces March 11. The company says the letter is largely consistent with the feedback it received from an FDA advisory committee in December; the panel voted 16-1 with one abstention against Imagify approval due to evolving trial design standards, miscommunication with the FDA review division, inconsistent efficacy, safety signals and unconvincing diagnostic value (1"The Pink Sheet," Dec. 15, 2008, p. 17). Acusphere submitted a narrower claim for the imaging agent in February with a potentially improved risk-benefit ratio, and is in the process of scheduling a meeting with FDA to discuss alternatives