In January 2024, the FDA approved Hyqvia (Immune Globulin Infusion 10% [Human]) as a maintenance therapy for adults living with chronic inflammatory demyelinating polyneuropathy (CIDP), a rare neurological disorder.
As an exciting follow-up, biotechnology company Halozyme Therapeutics, Inc. recently shared that the European Commission followed suit. The European Commission approved Hyqvia that is co-formulated with ENHANZE drug delivery technology. Patients can subcutaneously infuse themselves with treatment at home (following training) or can visit their doctor once each month.
More specifically, this approval centers around the use of this co-formulation in people, regardless of age, whose conditions stabilized while on IVIG treatment. Now, the therapy should be available for all members of the European Union, Iceland, Northern Ireland, Norway, and Liechtenstein.
Hyqvia is also approved to treat primary immunodeficiency.
Understanding Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Chronic inflammatory demyelinating polyneuropathy is a rare disorder that affects the peripheral nerves. Many people theorize that CIDP is an autoimmune disorder, a condition in which the body’s immune system mistakenly attacks healthy tissue. In this case, the immune system attacks the myelin sheath, or the protective coating of nerve cells. The myelin becomes degraded and destroyed. As a result, nerve fibers are unable to transmit nerve signals as quickly. Eventually, this leads to sensory loss and muscle weakness.
This condition is most common in young adult males, though it can happen in people of all backgrounds and ages. CIDP symptoms typically develop slowly and often manifest over periods of eight weeks or more. People with chronic inflammatory demyelinating polyneuropathy may experience:
- Tingling or loss of feeling in the fingers and toes
- Vocal changes such as slurred speech or hoarseness
- Loss of deep tendon reflexes
- Muscle weakness in the arms, legs, hands, and feet
- Difficulty walking
- Sensation changes such as decreased sensation, pain, or burning
- Issues with balance and coordination
- Difficulty breathing
It is possible to treat CIDP and enter remission. Potential treatment options, outside of the newly approved Hyqvia, include Gammagard Liquid (also newly approved), corticosteroids, plasmapheresis, and IVIG.