Wright Medical to Submit More Data to Support FDA Approval of Augment Bone Graft

Wright Medical Group Inc. today reached an agreement with the Office of Device Evaluation (ODE) of the U.S. Food and Drug Administration (FDA) under which ODE will accept a further amendment to the pre-market approval application for the company’s Augment bone graft in lieu of proceeding with the dispute resolution panel (DRP) that was scheduled for May 19. The agreement with ODE remains subject to final approval by the FDA appeal authority.

According to the company, the approval is expected soon.

Augment was part of Wright’s purchase of BioMimetic Therapeutics in 2012. The FDA issued a non-approvable letter in August last year as a result of what the agency considered flaws in the clinical trial’s patient population.

The PMA amendment, which the company expects to submit on or about March 31 will consist of analyses of pre-existing radiographic films of clinical study patients at pre-operative and post-operative time points. ODE has committed to an expeditious review of the PMA amendment and agreed to issue a determination on whether the PMA is approvable no later than 180 days after submission of the PMA amendment.

The company intends to renew the DRP process if the PMA amendment fails to result in a reversal of ODE’s previous not approvable determination.

“Since inception of the DRP process, Wright and ODE were encouraged by the FDA ombudsman to continue discussing alternative ways to resolve the dispute,” said Robert Palmisano, president and CEO of Wright. “These discussions proceeded slowly but gathered steam in recent days as the timeline for DRP submissions grew nearer. The result is something we consider to be a good mechanism for moving forward.”

While Palmisano continued noted that the move is cause for “greater optimism,” both sides are “still far apart,” adding that is no guarantee the PMA amendment will result in an approval.

“Nevertheless, we are pleased we were able to work collaboratively with FDA to identify a path forward that does not require new clinical studies to get to the next approvability determination,” he said.

Memphis, Tenn.-based Wright Medical Group makes extremity and biologic solutions.