FDA Asks BioMimetic for More Info

BioMimetic Therapeutics Inc. has a little more work to do before the U.S. Food and Drug Administration (FDA) approves its premarket approval (PMA) application for its Augment bone graft product, which is intended as a substitute for autograft (harvesting bone from a patient) in foot and ankle fusions.

The agency is asking for more information.

The company had been gunning for FDA approval of the device by the end of 2011. But the Nashville, Tenn.-based biotechnology company reported that the FDA said the technology could not be green-without additional information relating to Augment’s safety and effectiveness.

Though an FDA advisory panel voted in favor of a reasonable assurance of safety, effectiveness and a positive benefit-to-risk ratio, a letter from the FDA said: “notwithstanding [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 . . .”

The FDA then listed the information that BioMimetic would need to submit for the application to be approvable, and outlined a pathway that could potentially lead to approval without additional clinical trials to support the safety and effectiveness of Augment.

The company plans to answer the FDA by mid-2012, and that approval could follow within the next 15 to 24 months if the agency is satisfied with the responses.

In the letter, the FDA requested that the company submit additional information from the Augment pivotal study as it relates to the product’s safety and effectiveness, as well as additional information relating to antibody safety and reproductive issues. The FDA also requested t additional information relating to post-approval studies to monitor the cancer safety of the product and further evaluate its pharmacokinetic profile in humans.

“Although the company is confident that it can address the issues raised by the FDA, there is no assurance that the FDA will be satisfied with the response,” BioMimetic officials said in a statement. “The company continues to believe in the safety and effectiveness of Augment and remains optimistic about obtaining FDA approval.”

The company’s leadership also noted that it is “encouraged” by its dialogue with the FDA and the agency has indicated a willingness to work constructively with BioMimetic in a timely manner to resolve the issues outlined in the letter. The agency noted throughout the letter, however, that if the BioMimetic cannot provide the requested additional information, the additional information does not address FDA’s issues, or it raises new concerns, a new clinical trial may be required.

BioMimetic is a biotechnology company specializing in the development and commercialization of clinically proven products to promote the healing of musculoskeletal injuries and diseases, including therapies for orthopedics, sports medicine and spine applications. All Augment-branded products are based upon recombinant human platelet-derived growth factor (rhPDGF-BB), which is an engineered form of PDGF, one of the body’s principal agents to stimulate and direct healing and regeneration.

BioMimetic received regulatory approval in 2009 and 2011 to market Augment in Canada, and in Australia for hind-foot and ankle fusion indications. Augment is pending regulatory decisions in the United States and European Union for similar indications.