FDA rejects Intarcia's exenatide implant for the treatment of type 2 diabetes

Intarcia Therapeutics said the FDA issued a complete response letter regarding a filing seeking approval of its ITCA 650 implant, which is designed to treat type 2 diabetes via the continuous subcutaneous delivery of exenatide. The company indicated that it "does not anticipate the need to conduct new pivotal trials or any long lead-time CMC [chemistry, manufacturing and controls] activities in order to satisfy the requirements of the FDA."

According to Intarcia, the FDA provided "clear and constructive guidance…regarding manufacturing aspects" of the complete response letter, adding that the company is "working closely" with the agency on a path forward. CEO Kurt Graves remarked "we remain confident in the approvability of ITCA 650."

Intarcia said it remains in a "strong fiscal position," and has raised over $600 million through September 2017. The company noted that it also has multiple near-term milestones expected from its ex-US collaboration.

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In 2014, Intarcia licensed rights to ITCA 650 outside the US and Japan to Servier under a deal potentially worth more than $1 billion. Intarcia later unveiled top-line results from the Phase III FREEDOM-2 trial showing that ITCA 650 was superior to Merck & Co.'s Januvia (sitagliptin) at reducing both HbA1c and body weight in patients with type 2 diabetes.

AstraZeneca markets the GLP-1 receptor agonist exenatide as an injection under the names Byetta and Bydureon.

For additional analysis, see ViewPoints: Intarcia needs a quick fix.

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