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# Chiasma NDA Approved for Acromegaly
- URL: https://www.fdaweb.com/chiasma-nda-approved-for-acromegaly/
- Published: 2020-06-26T12:00:00.000Z
- Updated: 2026-09-14T16:19:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147107

FDA has approved a Chiasma NDA for Mycapssa (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Acromegaly is a rare chronic disease often caused by a benign pituitary tumor and characterized by excess production of growth hormone and insulin-like growth factor-1 hormone that is frequently treated with chronic burdensome injections, the company says. If left untreated, acromegaly can lead to serious, and sometimes life-threatening medical conditions.

The oral somatostatin analog was approved based on data from the pivotal Phase 3 CHIASMA OPTIMAL clinical trial that showed patients on therapy being able to maintain mean IGF-1 levels within the normal range at the end of treatment, it says. Adverse reactions observed in patients and described in the therapy’s prescribing information include cholelithiasis and complications of cholelithiasis, hyperglycemia and hypoglycemia, thyroid function abnormalities, cardiac function abnormalities, and decreased vitamin B12 levels and abnormal Schilling’s tests.