The FDA has for the second time issued a complete response letter to Intarcia Therapeutics regarding its ITCA 650 implant for the treatment of type 2 diabetes, the company confirmed on Wednesday. The drug-device combination consists of stabilised exenatide, a GLP-1 receptor agonist marketed by AstraZeneca as Byetta and Bydureon, delivered subcutaneously through Intarcia's Medici System over extended durations.
Intarcia stated that it was "extremely disappointed" with the FDA's decision, but "we remain steadfast in our belief that ITCA 650 holds important potential as a new treatment option for people managing type 2 diabetes." According to the company's website, ITCA 650 has the potential to offer patients a six-month exenatide treatment, while a full-year dose is in development, "[eliminating] the need for patients to adhere to daily or weekly injection for GLP-1s."
The FDA initially rejected the implant in 2017. At the time, Intarcia said the agency had provided guidance regarding "manufacturing aspects" of the complete response letter, but noted it did not anticipate having to "conduct new pivotal trials or any long lead-time CMC [chemistry, manufacturing and controls] activities" in order to address FDA concerns. The company resubmitted a filing in October last year (for related analysis, see ViewPoints: Have Intarcia's high hopes for ITCA 650 aged well?).
Intarcia provided no details of the complete response letter this time around, only saying "we anticipate meeting with the [FDA] for our end-of-review meeting to make sure we understand the situation and the path forward."
The company licensed rights to ITCA 650 outside the US and Japan to Servier in 2014 under a deal potentially worth more than $1 billion. It later unveiled top-line results from the Phase III FREEDOM-2 trial showing that ITCA 650 was superior to Merck & Co.'s DPP-4 inhibitor Januvia (sitagliptin) at reducing both HbA1c and body weight in patients with type 2 diabetes.
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