FDA Says No To BioMimetic Bone Graft Device, For Now

The U.S. Food and Drug Administration BioMimetic Therapeutics, Inc. recently announced that it received a comprehensive post-panel response letter from the U.S. Food and Drug Administration (FDA) concerning BioMimetic’s Pre-Market Approval (PMA) application for Augment® Bone Graft. The Bone Graft Device was intended for use as an alternative to autograft in hindfoot and ankle fusion procedures.

BioMimetic Therapeutics Inc. said the agency refused approval of its Augment® Bone Graft without additional prior study data, said The Wall Street Journal. The device maker also said that the FDA “outlined a pathway that could potentially lead to approval without additional clinical trials,” according to The Journal.

Last May, an FDA advisory panel backed Augment—a synthetic bone fusing device for foot and ankle surgeries—in a 10-to-8 vote in which the panel concluded that the device’s benefits outweighed its risks, explained The Journal. In a 12-to-6 vote, the panel found that there was a “reasonable assurance” of safety; a 10-to-8 vote indicated that the panel found the device to be effective. Although, in the aggregate, votes amounted to a panel recommendation that the agency should approve the device, the FDA considers such tight votes to be a split decision, said The Journal.

The FDA stated that “[n]otwithstanding [the Advisory Panel’s] recommendation, the PMA, without additional information, must be considered not approvable [and that]. . . to place [the Company’s] PMA in approvable form, [the Company] must amend it to include the following . . .,” said BioMimetic. The agency detailed what BioMimetic is required to submit to obtain application approval, including no additional clinical trials to support Augment’s safety and efficacy, said BioMimetic.

In addition to the prior Augment pivotal study data, the FDA has asked for more information on antibody safety and reproductive issues, more data on post-approval studies meant to monitor the device’s cancer safety, and additional evaluation of its pharmacokinetic profile in humans, said The Journal. According to BioMimetic, if it provides the requested information in a timely and satisfactory manner, Augment could receive approval in 15-24 months.

Based on BioMimetic’s assessment of the letter, the FDA’s key requests for additional information regarding the pivotal study include:

  • A re-reading of all 24-week CT scans conducted by the original musculoskeletal radiologist, as well as at least one additional radiologist, and an additional statistical analyses that correlates the radiological outcomes to the clinical outcomes. This is meant to enable the agency review the data’s “robustness,” given the differences in the outcome of the intent-to-treat and the modified-intent-to-treat patient population analyses
  • ;

  • Further review of serious study adverse events and re-categorization of secondary surgeries as failures;
  • Re-layer results by subgroup patient populations, such as patients with degenerative disease or with specific risk factors (smoking, diabetes, obesity), as well as by subgroup data based on the amount of Augment or autograft used.
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