- The Food and Drug Administration will permit Intarcia Therapeutics to request a public advisory committee hearing for its diabetes drug-eluting implant following two previous rejections over its kidney and heart risks.
- Intarcia has until Feb. 24 to make its request. If it follows through, the agency will convene a meeting of its Endocrinologic and Metabolic Drugs Advisory Committee within 120 days. The letter, signed by FDA Chief Scientist Namandjé Bumpus, cited “numerous disputes” between Intarcia and drug reviewers, adding that “a public hearing before an advisory committee could aid in the resolution of the parties’ disputes.”
- Called ITCA 650, Intarcia’s implant releases over year a steady flow of the active drug contained in Bristol Myers Squibb’s shot Bydureon, compared to the weekly or daily shots required for similar drugs. The company raised more than $1 billion in private funding and at one point was valued at $5 billion before it ran into difficulties with the FDA.
Intarcia was one of the high-flying companies that emerged from the investment money that flooded into small biotechnology companies in the 2010s. Its strategy was to outmaneuver the makers of weekly glucose-lowering shots called GLP-1s — Eli Lilly with Trulicity and Novo Nordisk with Ozempic — by offering a product that could have the same benefit for a year.
In addition to lowering blood sugar, drugs in this class have also been approved for weight-loss in overweight and obese people.
Intarcia’s matchstick-sized device is meant to be placed under the skin of the abdomen and slowly pump out exenatide, an early entrant in the GLP-1 class. (An extended-released formulation of the drug can be dosed once weekly.)
The device technology itself was thought to offer opportunities in other diseases. The Bill & Melinda Gates Foundation, for instance, invested in the company because it saw an opportunity to use the device to deliver long-acting HIV drugs.
In Phase 3 trials, ITCA 650 bested Merck & Co.’s Januvia on blood sugar lowering. However, when the data reached FDA drug reviewers, they rejected the company’s application on several grounds. The trials identified a kidney safety risk greater than that of other GLP-1s and Intarcia’s proposed risk-mitigation strategy was inadequate, the FDA said, which also noted evidence of greater cardiovascular complications and death in patients using ITCA 650.
The FDA identified additional problems with inconsistent drug delivery from the device as well as manufacturing deficiencies.
An Intarcia spokesperson didn’t respond to BioPharma Dive’s request for comment before publication.