FDA Says No to Wright Medical Biologics Product

Arlington, Tenn.-based Wright Medical Group Inc. received disappointing news from the U.S. Food and Drug Administration (FDA) about its Augment bone graft for use as an alternative to autograft in hindfoot and ankle fusion procedures. The FDA responded to the company’s pre-market approval (PMA) application with a not approvable letter—which literally means that the product is not approvable and can’t be sold in the United States—and based its rejection of the application on the clinical trial.

Augment is a product developed by BioMimetic Therapeutics Inc., which was bought by Wright in March this year.

In the letter, the FDA stated it is “concerned that the population enrolled was predominantly low risk and, therefore, may not have warranted the use of either autograft or Augment bone graft.” The agency went on to state it believes that “it will be necessary to perform a new clinical study that evaluates the use of Augment bone graft as a substitute for autograft in hindfoot and ankle fusion procedures in a well-defined high-risk target population, where the use of autograft would be clinically warranted.”

In summary, the FDA concerns included “the patient population studied in the clinical study, the amount of graft material implanted, and the uncertainty as to whether any graft material would be needed or if the use of no graft material in a fusion procedure of the hindfoot and ankle in the population studied would have achieved similar results.”

According to Wright, the FDA provided a number of additional observations about the clinical study design and results. However, Wright President and CEO Bob Palmisano said during a conference call that the company would not be releasing or publishing the not approvable letter, as he was certain the agency would be unhappy if it did.

During the conference call, which was held on Aug. 8, Palmisano said, “Needless to say, we are very disappointed by the FDA’s decision to issue a not approvable letter for our PMA application for Augment bone graft. This is not what we expected, as we believed that all of the FDA’s concerns as outlined in their previous not approvable letter from December 2011 had been fully and thoroughly addressed in the PMA amendment that BioMimetic submitted in June 2012. We are continuing to study the FDA’s position and expect we will work collaboratively with the agency to determine an appropriate path forward.”

In the letter, the FDA encouraged Wright to make use of the appeal process. Palmisano said the company would definitely be making use of that opportunity in order to understand what exactly the agency wanted from the clinical trial that it deemed not high-risk enough.

“We have to understand more thoroughly and clearly the FDA’s position and how they got there,” Palmisano said. “When you get a letter like this, you’re shocked and disappointed and you try to think about what we’re going to do next. I’m trying to calm all our folks down to make sure we approach this calmly and logically.”

The CEO also said that Wright will be evaluating what it will do in its international markets. Currently, theproduct is being marketed sold in Canada, Australia and New Zealand by BioMimetic.

“There is the opportunity for CE mark, but we have to decide if that’s something we should do,” he said, referring to the approval designation from the European Union. “We are selling our product pretty robustly in Australia, and also have business in Canada, and I would say that that will continue to be business as usual.”

The FDA’s main concern seemed to be that the patient population studied was not high-risk enough. During the Wright conference call, a participant asked the executives present why they thought the FDA took this stance. The questioner pointed out that there were a lot of smokers, diabetic patients and obese patients in the study, and didn’t understand “how it could get any more high risk.” Another participant noted that Augment’s labeling in Canada and Australia had no reference to high-risk patients.

Palmisano said that as he understood it, autografts are determined by physicians who decide whether a patient will benefit from one or not. He said he looks forward to speaking with the FDA “face to face” to find out why they require a higher-risk population and what that would entail.

As of now, Wright Medical executives are not sure whether a new clinical trial would be worthwhile, especially if ultimate approval is not certain. The company will release more information once it meets with the FDA.