FDA once again rejects Intarcia's 6-month diabetes drug implant

Typically a twice-daily or once-weekly injection, Intarcia’s formulation aims to stabilize the GLP-1 agonist exenatide, to keep it viable at human body temperatures for about six months. (Image: Intarcia)

It’s been over two years since its last rejection by the FDA, but now Intarcia Therapeutics finds itself once again in the same spot with its matchstick-sized, long-term drug implant for type 2 diabetes.

The agency delivered its second complete response letter to the company for its ITCA-650 implant—a small, osmotic pump designed to be slipped under the skin and deliver a continuous, six-month dose of the GLP-1 agonist exenatide, also sold as Byetta and Bydureon.

Typically a twice-daily or once-weekly injection, Intarcia’s formulation aims to stabilize the drug to keep it viable at human body temperature for extended periods of time. The company has also been working to develop its Medici pump delivery system for use against HIV and other indications, and over its 25-year lifetime has raised well over $1 billion in venture capital funding for its efforts.

But in September 2017, the FDA handed back Intarcia’s application for its most advanced clinical candidate, citing issues in the type 2 diabetes implant’s manufacturing, according to the company. At the time, Intarcia said it received constructive guidance from the agency and was on a path to move forward.

RELATED: Months after FDA rejection, Intarcia cuts 60 jobs and halts 2 late-stage trials

The following February, the company laid off 60 employees in a restructuring plan that also canceled two phase 3 trials, which it said were not required at the time for its pursuit of FDA approval. This included one test of the long-term implant against approved prescriptions for type 2 diabetes, and another exploring its use in patients with high baseline HbA1c levels. 

Intarcia’s resubmitted ITCA-650 application was accepted by the agency over a year-and-a-half later, in October 2019. In statements to Endpoints and Stat, the company said it remains committed to the product’s potential in type 2 diabetes, and is looking forward to its next meeting with the FDA to decide on next steps.