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Akcea cuts 10% of staff following FDA rejection

Published on 10/09/18 at 11:17am

Akcea Therapeutics has been hit hard by the FDA’s decision to reject its drug Waylivra (volanesorsen) for the treatment of familial chylomicronaemia syndrome (FCS), a genetic disease characterised by the accumulation of fat in the blood. The company announced that it had taken the decision to cut its workforce as a result of the ruling.

Akcea received a complete response letter from the US agency last month alerting it to the rejection decision, which is believed to revolve around concerns over platelet declines as a result of Waylivra’s use which forced five participants to discontinue a Phase 3 trial.

As a result, the company confirmed it would be stripping away around 10% of its workforce, cutting down from its current total of 270 in a move “to reorganise its workforce to better align with the immediate needs of its business”.

Akcea has publicly stated that it is working to address the Waylivra’s efficacy concerns with data derived from its ongoing open-label extension study and/or early access programme, and plans to meet the FDA to determine the best path forward.

Matt Fellows

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