Ionis Pharmaceuticals’ (IONS) Volanesorsen is a drug for the treatment of familial chylomicronemia syndrome (or FCS) and familial partial lipodystrophy (or FPL). The drug reduces apoC-III protein production and lowers triglycerides in patients with dyslipidemia.
The above chart shows recent developments for Volanesorsen. The drug is classified under severe and rare therapeutic areas. Akcea Therapeutics (AKCA), a subsidiary of Ionis, is engaged in pre-commercialization activities for Volanesorsen and plans to commercialize the drug once it receives approvals from the US Food & Drug Administration (or FDA) and the European Commission. The drug has been granted the “Orphan Drug” designation for the treatment of FCS.
Present status of Volanesorsen
On November 15, 2017, Ionis announced that the US FDA had assigned the drug a Prescription Drug User Fee Act (or PDUFA) date of August 30, 2018. Also, Health Canada has granted priority review to the new drug submission of Volanesorsen for the treatment of FCS. Plus, the European Medicines Agency has validated the marketing authorization application for Volanesorsen, while the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (or MHRA) has granted its “Promising Innovative Medicine” designation to Volanesorsen for the treatment of FCS.