Volanesorsen

Overview

Volanesorsen is an antisense oligonucleotide that binds to apoC-III mRNA to prevent its translation. It is indicated to treat familial chylomicronemia, a genetic condition that prevents breakdown of triglycerides and chylomicrons. This drug is not commonly prescribed as it is used as an adjunct to diet in patients at high risk for pancreatitis, who have had inadequate response to triglyceride lowering therapy. Volanesorsen was granted a conditional approval by the European Medicines Agency.

Indication

Volanesorsen is conditionally approved by the EMA as an adjunct to diet in adults with familial chylomicronemia, at high risk for pancreatitis, and who have had an inadequate response to diet and triglyceride lowering therapy.

Associated Conditions

Familial Chylomicronemia Syndrome (FCS)

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Volanesorsen Early Access Program for Patients With Familial Chylomicronemia Syndrome (FCS)	2018/06/01	NCT03544060	N/A	NO_LONGER_AVAILABLE	Akcea Therapeutics
A Study to Evaluate the Effect of Volanesorsen on Cardiac Repolarization Conducted in Healthy Volunteers	2016/09/22	NCT02910635	Phase 1	Completed	Ionis Pharmaceuticals, Inc.
The Approach Open Label Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Chylomicronemia Syndrome	2016/01/18	NCT02658175	Phase 3	Completed	Akcea Therapeutics
Efficacy, Safety and Tolerability of ISIS 304801 in People With Partial Lipodystrophy With an Open-Label Extension	2015/12/24	NCT02639286	Phase 2	Completed	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The BROADEN Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Participants With Familial Partial Lipodystrophy	2015/08/19	NCT02527343	Phase 2	Terminated	Akcea Therapeutics
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia	2014/11/24	NCT02300233	Phase 3	Completed	Ionis Pharmaceuticals, Inc.
The APPROACH Study: A Study of Volanesorsen (Formerly IONIS-APOCIIIRx) in Patients With Familial Chylomicronemia Syndrome	2014/08/07	NCT02211209	Phase 3	Completed	Ionis Pharmaceuticals, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Waylivra	Akcea Therapeutics Ireland Limited,Akcea Therapeutics Ireland Limited,St. James House,72 Adelaide Road, Dublin 2,D02 Y017,Ireland	Authorised	5/3/2019

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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