Commentary: Shame on the FDA! If you replay the tape here you will find that the FDA approved the study protocol, the company then met the endpoints in the study, the FDA Panel approved it, and then the FDA denied it… and then 4 years later approved it. This irrational behavior spooks the investment community.
Wright Medical Receives FDA Clearance for its Premarket Approval Application of its AUGMENT Bone Graft (HealthPointCapital)
Wright Medical announced that its BioMimetic subsidiary received approval from the FDA for its Premarket Approval Application (PMA) for its AUGMENT Bone Graft, indicated as an alternative to autograft for ankle and/or hindfoot fusion procedures.
AUGMENT is the first clinically proven protein therapeutic (Growth Factor) product to come to the U.S. orthopedics market in over a decade. Growth Factors are a group of soluble proteins that bind onto cell surface receptors, triggering a series of signals that regulate the body’s ability to grow, renew and heal. Presently, there are only two other recombinant growth factors available on the market, Medtronic’s INFUSE (indicated for degenerative disc disease in the spine, and lower leg and dental procedures) and Stryker’s OP-1 (indicated for long bone non-unions).
AUGMENT is the combination of two components, recombinant human Platelet-Derived Growth Factor (rhPDGF) and Beta-tricalcium phosphate (Beta-TCP). rhPDGF provides a biological stimulus for the recruitment and proliferation of cells, including osteoblasts, which are responsible for the formation of new bone, while Beta-TCP provides a framework (or scaffold) for the new bone growth.
The clinical literature for AUGMENT demonstrates a healing rate and safety profile equivalent to autogenous bone graft, which not only provides patients a new therapeutic alternative for ankle and/or hindfoot fusion procedures, but also gives patients an option to avoid the additional surgery required to harvest the autograft bone graft tissue, which can result in site-specific complications and/or prolonged harvest site pain.
In August 2013, the FDA communicated that it would not approve Wright’s PMA application for AUGMENT, noting that the agency remained concerned that the population enrolled in the clinical trial was predominantly “low-risk” and therefore the patients may not have warranted the use of either autograft or AUGMENT to achieve a successful fusion at all. There was also concern surrounding the amount of graft material implanted. However, in November 2013, the company appealed to the FDA, which agreed to withdraw its not approvable letter and establish Medical Dispute Resolution Panel (DRP), giving Wright a chance to persuade the FDA to reverse its prior ruling.
Wright expects to begin selling AUGMENT on the U.S. market within the next several weeks once the company’s inventory is moved throughout its distribution network. Management anticipates AUGMENT revenues in the U.S. to be in the range of $10 – $12 million in the first seven to eight months post-approval.