Argenx Gains Health Canada Approval For Vyvgart SC As Monotherapy In CIDP

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(RTTNews) - argenx SE (ARGX), Wednesday, announced that Health Canada has issued a Notice of Compliance authorizing VYVGART SC as a monotherapy for the treatment of adult patients with active chronic inflammatory demyelinating polyneuropathy.

VYVGART SC is authorized for CIDP as a once weekly 20-30 second subcutaneous injection in a prefilled syringe, offering patients the flexibility to self-administer or receive treatment from a caregiver or healthcare professional--at home, while 'on the go,' or in a clinical setting. With this milestone, VYVGART SC becomes the first innovative treatment for CIDP in more than 30 years, and the first-and-only neonatal Fc receptor (FcRn) blocker authorized in Canada for CIDP.

"There remains a significant unmet need among Canadians living with CIDP, who face progressive weakness, numbness and disability," said François Jacques, M.D., Neurologist, Clinique Neuro-Outaouais. "The authorization of VYVGART SC brings a novel, targeted therapy that offers a new way of treating patients, with meaningful improvements in strength and function."

CIDP is a rare, debilitating and often progressive autoimmune disorder of the peripheral nervous system. People living with CIDP experience a range of disabling mobility and sensory issues, such as difficulty standing from a seated position, pain, fatigue, and frequent tripping or falling. As the disease progresses, patients may require the use of a wheelchair and may be unable to work or participate in daily activities. Globally, 85% of patients require ongoing treatment and nearly 88% of treated patients continue to experience residual impairment and disability.