European MAA Status
The Company completed Marketing Authorisation Application (MAA) pre-submission meetings with the European Medicines Agency (EMA) and assigned rapporteurs. The Company believes that the existing efficacy and safety data may be adequate to support approval in Europe because: 1) the data support that Imagify™ (perflubutane polymer microspheres) injectible suspension with ultrasound has equivalent efficacy to nuclear stress testing and has a safety profile that is appropriate for the intended patient population, 2) under European guidelines, placebo trials are not required for EMA approval (unlike FDA’s requirement for a placebo trial before U.S. approval) and 3) radiation safety is a significant benefit of Imagify compared to nuclear stress and this benefit may be factored into the risk-benefit assessment at the core of the approval decision in Europe, where radiation safety is taken much more seriously than in the U.S. Once approved, Imagify stands to become the first ultrasound contrast agent approved anywhere in the world for myocardial perfusion assessment.
U.S. Regulatory Status
Acusphere is in the process of working with FDA on a Special Protocol Assessment (SPA) that will define the remaining requirements for approval in the U.S. Acusphere has reached agreement with FDA on the overall design of a placebo trial, comparing ultrasound with Imagify to ultrasound without Imagify. As background, the FDA accepted Acusphere’s New Drug Application (NDA) for filing in June 2008 and in February 2009 sent a Complete Response Letter (CRL) to the NDA.