The FDA extended the PDUFA goal date of Akcea's hereditary TTR amyloidosis drug inotersen to October 6, 2018.
“The FDA has extended the review period for TEGSEDI and has assigned a new PDUFA goal date of . The determined that they need additional time to review our responses to their standard information requests and we are working closely with them to advance the review of our filing as quickly as possible,” said Sarah Boyce, president of Akcea. “Additionally, our discussions with the EU and continue to progress well. We are moving forward at full speed to bring TEGSEDI to people with this devastating and fatal disease as quickly as possible after approval.”
The delay puts Alnylam in the lead to get it's drug, patisiran, on the market several months before Ackea.
The prevalence of hereditary TTR amyloidosis in the U. S. is around 1 in 100,000.
As of this writing, Ackea's shares were down a little over 5%.