Takeda’s HyQvia has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a maintenance therapy for the rare neurological disorder chronic inflammatory demyelinating polyneuropathy (CIDP).
HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) can now be used in patients of all ages with CIDP following stabilisation with intravenous immunoglobulin therapy.
CIDP is characterised by progressive weakness and reduced sensation in the arms and legs. The condition can be diagnosed at any age and results from damage to the myelin sheath, the fat-based protective covering on nerves.
Immunoglobulin therapy is considered the standard-of-care for CIDP maintenance treatment. However, there are aspects of intravenous immunoglobulin treatment that can be challenging for patients, including long treatment durations and the potential for venous access challenges.
As the only facilitated subcutaneous immunoglobulin treatment in the UK, HyQvia offers patients with CIDP a typical dosing interval of four weeks.
“As many as 650 people are diagnosed with CIDP each year in the UK, and the condition has a huge impact on someone’s life,” said Rich Collins, chief executive of GAIN, the main patient advocacy group for those with CIDP.
“It is vitally important that people with this rare condition are supported effectively, and personalised support is prioritised. It’s really great to see continuing steps forward for people with CIDP,” he added.
The therapy is already approved by the MHRA as a replacement therapy for certain patients with primary immunodeficiency and secondary immunodeficiency.
The latest approval comes shortly after HyQvia was approved by the European Commission, also as a maintenance therapy for CIDP patients of all ages.
Kristina Allikmets, senior vice president and head of research and development for Takeda’s Plasma-Derived Therapies Business Unit, described the January authorisation as “a critical step towards giving people in the EU living with CIDP access to a maintenance treatment with proven efficacy that can be administered up to once monthly, at-home or in-office”.
HyQvia was also recently approved by the US Food and Drug Administration as a maintenance therapy to prevent the relapse of neuromuscular disability and impairment in adults with CIDP.