Akcea Therapeutics finally earned a U.S. drug approval. The Food and Drug Administration announced Friday it had approved the company’s drug, inotersen (Tegsedi), which aims to treat a rare and fatal condition known as hATTR.
It’s a major win for Akcea, after the FDA declined to approve another of the company’s drugs, Waylivra, based on the same technology. But Tegsedi was approved with a black box warning — the strongest type the FDA can put on a prescription drug. The warning is about the platelet issues that also dogged Waylivra as well as a type of kidney inflammation.
“Today marks an important day for Akcea and Ionis, and we’re ready to go,” CEO Paula Soteropoulos said on a conference call after the announcement. Tegsedi was developed by Ionis Pharmaceuticals and licensed to Akcea.
About the Author Reprints
Onpattro list price is $450k for patients less than 60kg. It’s $550k for larger patients