Akcea Therapeutics is laying off 10% of its workforce. The cuts come 10 days after the FDA rejected a filing for approval of volanesorsen and left Akcea with little use for the team it built up to promote the ultrarare lipid disorder drug.
Ionis spinout Akcea looked to be sailing toward an FDA approval in May when an advisory committee narrowly voted in favor of volanesorsen. The situation changed last week when the FDA went against the advisory committee and issued a complete response letter. Akcea has said little about why the FDA rejected the drug or what it needs to do to win over the agency.
While the secrecy around those details remains, Akcea’s actions show the delay will be long enough that it makes no sense to keep the field team and other staff tasked with supporting the introduction of volanesorsen. Akcea is laying off these employees.
Akcea had built its headcount to 270 in anticipation of bringing volanesorsen to market under the brand name Waylivra, according to Reuters. That suggests close to 30 people will be affected by the layoffs. All the affected employees are based in the U.S. and involved in functions related to the rejected lipid disorder drug. Akcea will incur costs of up to $2.5 million related to the restructuring.
The longer-term situation is less clear, primarily because of Akcea’s secrecy. Management has said little to analysts or the media about the reasons for the FDA rejection, leaving observers to make educated guesses based on the issues the agency raised in its briefing documents.
Further details should emerge once Akcea has worked through the feedback provided by the FDA and met with the agency to discuss its implications for the prospects of volanesorsen.