Delay at FDA for inotersen to treat hereditary TTR amyloidosis.- Akcea Therapeutics

The FDA has delayed the PDUFA date for Akcea's hereditary TTR amyloidosis drug, inotersen, (now known as Tegsedi). The FDA has asked for more time to review its response to requests for information on the rare disease antisense drug. Inotersen was accepted for priority review at the start of 2018 with a possible, 6 July decision.

Ionis made the filing before licensing inotersen to its affiliate Akcea in March 2018. At that point, inotersen looked set to precede Alnylams other TTR drug patisiran to market but that is not now likely to happen. By the time the FDA completes its review of inotersen, patisiran should already have been approved.

Comment: Inotersen is seen as having better Phase III results than patisiran.