Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
Pictured: People in suits with their thumbs down/iStock, iammotos
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Thursday unanimously voted against Intarcia Therapeutics’ investigational drug-device combination product ITCA 650 (exenatide in DUROS device) for the treatment of type 2 diabetes.
All 19 panelists found that the benefits of the implantable drug-device combination did not outweigh its risks from potential side effects. In particular, the panel flagged the high rate of acute kidney injury in patients assigned to the treatment group, which they contend could potentially be attributed to ITCA 650.
Even if the acute kidney injury episodes were triggered by other external causes, “does having the device in place exacerbate it?” asked Patrick Nachman, a panel member and director of the Nephrology and Hypertension division at the University of Minnesota, during Thursday’s advisory committee meeting.
The external experts made the case that there’s a lot of uncertainty regarding the safety profile of ITCA 650 with the need for additional data, which they suggested Intarcia could collect in larger trials.
Thursday’s adcomm defeat is the latest in ITCA 650’s troubled regulatory history. The FDA issued its first Complete Response Letter (CRL) for the implantable device six years ago, in September 2017, citing manufacturing issues. The company resubmitted its application more than two years later, in October 2019, which the FDA considered as a complete response to the initial CRL.
The regulator nevertheless rejected the resubmission, issuing a second CRL in March 2020. The company at the time said that it would seek a meeting with the FDA’s Division of Metabolic and Endocrinology Products to better understand the regulatory path forward for ITCA 650. These two rejections also pushed the company to seek an advisory committee meeting, according to STAT News.
Using Intarcia’s proprietary Medici Drug Delivery System, ITCA 650 is a matchstick-sized mini osmotic pump designed to continuously deliver a therapeutic molecule just beneath the skin over six months. Placed in a patient’s abdominal area, the drug-device combination is designed to potentially reduce injection frequency and improve patient adherence.
The active ingredient in ITCA 650 is exenatide, which belongs to the drug class called GLP-1 receptor agonists along with Novo Nordisk’s Ozempic (semaglutide) and Lilly’s Trulicity (dulaglutide). Exenatide has also been approved by the FDA and is sold under the brand names Byetta and Bydureon.
As in the case of ITCA 650, Byetta and Ozempic also come with safety concerns for acute kidney injury, as indicated by their labels.
A former biotech unicorn, Intarcia’s assets—including ITCA 650—were acquired last month by private company i2o Therapeutics.
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
