NICE u-turn sees Akcea’s Waylivra win NHS funding
The drug is the first and only therapy for the ultra rare condition Familial Chylomicronaemia Syndrome (FCS)
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Tag: FCS
Waylivra granted conditional marketing authorisation in Europe
The authorisation follows the positive opinion recommending approval provided by the Committee for Medicinal Products for Human Use (CHMP).
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FDA rejects Akcea/Ionis’ rare disease drug Waylivra
US regulators have rejected Akcea/Ionis’ application to market Waylivra for the ultra-rare rare lipid disorder familial chylomicronemia syndrome (FCS).
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FDA advisors back approval of Akcea’s volanesorsen
Akcea Therapeutics’ volanesorsen has taken a step closer to becoming the first therapy on the US market for the ultra-rare rare lipid disorder familial chylomicronemia syndrome (FCS).
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UK patients get early access to Akcea’s volanesorsen
Akcea Therapeutics’ volanesorsen will be available to eligible patients in the UK before it is officially licensed in the EU, having been granted entry to the country’s Early Access to Medicines Scheme.
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Akcea’s rare lipid disorder drug wins PIM status
Akcea Therapeutics’s volanesorsen has been granted a Promising Innovative Medicine designation by the Medicines and Healthcare products Regulatory Agency for the treatment of familial chylomicronaemia syndrome, a rare genetic lipid disorder.
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