Two companies have been given the thumbs-up by the U.S. Food and Drug Administration (FDA) for kidney-related therapies. Hansa Medical (Lund, Sweden) has been granted FDA Fast Track Designation for its drug candidate imlifidase to help reduce kidney rejection in transplantation. Under this designation, the FDA process is designed to facilitate development and expedite the review of drugs that could treat serious conditions and fill an unmet medical need. Another company, MediBeacon Inc. (St. Louis, MO) has been granted a Breakthrough Designation for its transdermal measurement device for GFR, a designation given when a product may show improvement over available therapy.
Hansa Medical’s compound imlifidase is an enzyme in late-stage clinical development as a treatment to enable kidney transplantation for sensitized patients who previously were unable to undergo transplantation because of certain donor-specific antibodies.
“This Fast Track Designation is validation of imlifidase’s potential to address the significant unmet medical need for highly sensitized patients, a patient population for which transplantation is extremely difficult or impossible,” said Søren Tulstrup, president and chief executive officer of Hansa.
Efficacy data from four phase 2 studies demonstrated that imlifidase rapidly and significantly reduced donor-specific antibodies by cleaving IgG, enabling transplantation.
The company notes that current desensitization methods are not feasible for most highly sensitized patients.
MediBeacon Inc., whose largest shareholder is Pansend Life Sciences of HC2 Holdings, announced that the FDA has granted Breakthrough Device designation to MediBeacon’s Transdermal GFR Measurement System (TGFR). The device is intended to measure GFR in patients with impaired or normal renal function.
The FDA designated MediBeacon’s TGFR a combination product that includes an optical skin sensor, monitor, and MB-102, a proprietary fluorescent tracer agent that glows in the presence of light. The TGFR is designed for continuous real-time measurement of GFR at the point of care, without blood or urine collection.
“We are delighted that the FDA has recognized that the Transdermal GFR Measurement System meets the requirements for this designation,” said Steve Hanley, MediBeacon CEO. “We look forward to continued close collaboration with the FDA as we begin our pivotal multicenter clinical study in the United States and Europe.”
