Wright Medical (NSDQ:WMGI) said the FDA agreed to let it submit additional data for its pre-market approval application for the Augment bone graft it bought along with BioMimetic Therapeutics in 2012.
The FDA issued a non-approvable letter for Augment back in August 2013, citing the low-risk patient population in a clinical trial backing the U.S. approval application. Wright appealed and won a date with an FDA dispute resolution panel, but remained pessimistic that the hearing would go its way.
Today Wright said the federal watchdog agency agreed to let it submit more data for review by the FDA’s Office of Device Evaluation instead of proceeding with the dispute panel, which had need slated for the week of May 19. The deal must still be OK’d by the FDA’s appeals authority, according to a press release, but that’s expected to happen "shortly."
Memphis-based Wright said the additional data involves analyses of radiographic images taken pre- and post-operatively during clinical studies of the Augment product. The ODE has pledged to rule on the PMA amendment within 6 months submission, which Wright said is planned "on or about" March 31.
“The company intends to renew the [dispute resolution panel] process if the PMA amendment fails to result in a reversal of ODE’s previous not approvability determination," according to the release.
Last month, CEO Robert Palmisano said the medical device maker was not optimistic that the resolution panel would recommend a reversal of course. Wright bought BioMimetic Therapeutics, which makes the Augment product in Franklin, Tenn., for $190 million in cash and another $190 million is possible milestones in November 2012. In August 2013, the FDA said Wright would need to run a new clinical trial on high-risk patients to win its favor for Augment. Last November the federal watchdog agency granted Wright’s request for the dispute resolution panel. Wright has no plans to run another clinical trial for Augment and would move quickly to scale back the Augment business (except for a small but fast-growing operation in Australia) if the panel doesn’t go its way, Palmisano said in February.
"Since inception of the [dispute resolution panel] process, Wright and ODE were encouraged by the FDA ombudsman to continue discussing alternative ways to resolve the dispute. 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," Palmisano said yesterday in prepared remarks. "While this development is cause for somewhat greater optimism than we have thus far had reason to embrace, it is important to reiterate that the parties’ positions are still far apart and there is no guarantee this PMA amendment will result in an approval for Augment bone graft. 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."
