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# FDA OKs Akcea Therapeutics/Ionis Pharmaceuticals Drug
- URL: https://www.fdaweb.com/fda-oks-akcea-therapeutics-ionis-pharmaceuticals-drug/
- Published: 2018-10-08T12:00:00.000Z
- Updated: 2026-09-15T00:36:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142539

FDA has approved an Akcea Therapeutics and Ionis Pharmaceuticals NDA for Tegsedi (inotersen) for treating polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. Tegsedi is described as a RNA-targeting therapeutic that reduces the production of TTR protein through a once-weekly subcutaneous injection. Approval was based on data from the NEURO-TTR study, which demonstrated that the therapy produced up to a 79% mean decrease from baseline in serum TTR protein in patients regardless of TTR mutation, sex, age, or race.

  
The company says that Tegsedi is associated with risk of thrombocytopenia and glomerulonephritis. FDA is requiring a Risk Evaluation and Mitigation Strategy because enhanced monitoring is required to support early detection and management of these identified risks, the companies say.