Four months after the FDA rejected its diabetes drug-eluting implant, privately-held Intarcia Therapeutics has cut 60 employees and received a clinical hold for two of its ongoing marketing studies, according to reports.
The company’s device is designed for the continuous, subcutaneous delivery of exenatide in people with Type II diabetes. It was rejected by the U.S. regulatory agency in September, after the FDA found problems with the manufacturing process used to make ITCA 650.
The company’s CEO told The Boston Business Journal that although they laid off 60 employees, the company is hiring to fill to an array of open spots and expects that its total headcount will remain steady over the next few months.
The news outlet also reported last week that Intarcia ended two late-stage Phase III studies of its diabetes implant. The studies are not related to the company’s pivotal trial for ITCA 650, Intarcia told BBJ, and are not necessary for FDA approval.
The FDA placed a clinical hold on the studies after one of Intarcia’s third-party labs found a “out of specification” result when testing the company’s pumps. After Intarcia told the FDA about the investigator’s findings, the agency halted the studies.
Intarcia’s chief executive, Kurt Graves, told BBJ that the company hopes to eventually re-start similar marketing studies, which compared the product to already-approved therapies for Type II diabetes.
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