An FDA panel voted 6-5 yesterday in favor of approving Medtronic's Amplify, a BMP-2 with a different formulation and carrier than InFuse. Heading into the meeting, concerns circulated over a higher incidence of cancer in patients treated with Amplify, though the panel ultimately voted 9-4 in support of safety (with 1 abstention) and 10-3 (with 1 abstention) on efficacy. In the final 6-5 vote, which affirmed that the panel believed the product's benefits outweighed its risks, there were 3 abstentions.
Medtronic is seeking a single-level, posterolateral fusion indication. The FDA usually makes its final determination in line with the panel recommendation.
In addition to awaiting a verdict from the FDA, Medtronic is also facing a BMP payment review in the form of a CMS MedCAC panel. MedCAC will convene on September 22 to discuss the evidence in support of continued coverage of InFuse (and, potentially, Amplify) in the Medicare population, particularly as it pertains to off-label use. The AHRQ recently completed a technology assessment on BMP-2 and concluded that the data in support of radiographic fusion is "moderate," which is favorable, though the agency noted that is little evidence that BMP-2 improves other outcomes.
