BioMimetic Therapeutics (BioMimetic) has submitted the third and final module of its premarket approval (PMA) application for marketing Augment Bone Graft in the US. The final module, containing a comprehensive review of the clinical data related to Augment, completes the PMA application to the FDA.
BioMimetic previously announced the filing of both the pre-clinical pharmacology/toxicology and quality/manufacturing modules with the FDA in June 2009.
Upon receipt of the clinical module, the FDA begins its 45 day filing process as the first step in the formal review of the PMA. BioMimetic expects the agency to schedule an advisory panel review sometime later in the year.
A modular submission breaks the PMA document into sections or ‘modules’ filed at different times that together become a complete application. The modular approach allows the applicant to potentially resolve any concerns noted by FDA earlier than would occur with a traditional PMA application, and may shorten the review and approval timeline. In fact, the company has been responding to questions from the agency related to the first two modules for the past several months.
Samuel Lynch, president and CEO of BioMimetic, said: “The Augment PMA submission is an important milestone for BioMimetic and our commitment to advance first-in-class, innovative biologics that stimulate tissue regeneration in bone, ligaments and tendons. We are very encouraged by the results seen to date in Augment’s clinical development program and look forward to working with the FDA to facilitate the review and approval of this novel therapeutic.”