Avita Medical Ltd., a regenerative medicine company specializing in the treatment of wounds and skin defects, announced that the US FDA has ruled that the ReCell® Autologous Cell Harvesting Device is eligible for earlier regulatory approval for burns treatment in the United States.
The ruling came under new FDA guidelines called the Expedited Access Pathway (EAP), which are aimed at helping patients get more timely access to life-saving medical devices, while preserving the statutory standards of safety and effectiveness for Premarket Approval (PMA). In a written response to the
Company’s formal request for an EAP designation, the FDA said ReCell® meets the EAP criterion in that “the device may offer significant, clinically meaningful advantages over existing legally marketed alternatives.”
The FDA’s Center for Biologics Evaluation and Research (CBER) issued the designation, and will now enter into further discussions with Avita to resolve a data development plan that will describe the extent of preclinical and clinical data required to support the PMA. A strategic data development plan, combined with priority review, is anticipated to underpin an earlier timeline. Avita is currently near to completing enrollment in its FDA approval trial being conducted at seven of the nation’s leading burns centers, with 26 of the 30-patient target recruited. Prior to receiving the notice of EAP eligibility, the Company estimated that regulatory approval would come in Q3 2017, pending submission to the FDA of full safety and effectiveness data, under an application on the PMA regulatory route.
“The FDA’s decision that we meet the criteria tallies with our view that ReCell® is a unique offering for helping burns victims, and as such, approval would be preferable sooner than later,” said Andrew Quick, Avita’s Vice President of Research & Technology. “So we are very excited that we can now advance discussions with the Agency to determine exactly how this changes our timeframes.”
The FDA’s program is titled “Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.” It was introduced in April, and Avita is one of the first to achieve a designation of meeting the criteria. In addition to interactive review of a data development plan, the EAP program features involvement of senior FDA management and the use of a case manager. The scheme does not relax any of the FDA’s safety or effectiveness requirements, but allows early approval with commitments that all data will be submitted to the FDA under agreed timeframes.
The Company is also engaged with the FDA under a Compassionate Use program, under which US burns centers are able to use ReCell® when no other treatment is possible. The number of patients allowed to access this scheme was recently doubled to 24 based on demand from various burns surgeons, who have used the device with encouraging clinical outcomes. As such, the Company believes its credentials as a supplier of a life-saving device for burns are now achieving recognition in the US.
- FDA rules Avita’s ReCell® device is eligible for earlier regulatory approval under EAP guidelines
- FDA says device eligible because it may offer ‘significant, clinically meaningful advantages’ over other current alternatives in the US for burns treatment
- New approval date remains to be determined in follow-on discussions with the FDA
- Company now nearing completion of patient enrollment for US regulatory approval trial