Tegsedi: how long were the pivotal tox studies?

“In the 39-week study, inotersen was administered at doses of 0, 3, 6, 10, and 20 mg/kg once weekly.”

“Pivotal toxicity studies were conducted in CD-1 mouse (13-week [30-day interim] + 13-week recovery, 26-week + 13-week recovery), Sprague-Dawley rat (26-week), and cynomolgus monkey (13-week + 13-week recovery, 39-week [26-week interim] + 26-week recovery).”

“In all species, inotersen was administered by subcutaneous injection.”