Approvals

Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation to Hyqvia as a maintenance therapy for patients of all ages with chronic inflammatory demyelinating polyneuropathy (CIDP) following stabilisation with an intravenous immunoglobin therapy (IVIG).

Hyqvia is a ‘liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (IG) and is approved by the European Medicines Agency (EMA) and MHRA as a replacement therapy in adults, children and adolescents with primary immunodeficiency (PI) and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/L’, according to the company’s press release.

This marketing authorisation follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), announced on 15 December 2023, as well as an approval for use as a maintenance therapy for adult patients with CIDP from the US Food and Drug Administration (FDA) on 16 January 2024 and the European Commission (EC) on 29 January 2024.

Rich Collins, chief executive of patient advocacy group Guillain-Barré and Associated Inflammatory Neuropathies (GAIN), commented: “GAIN are always delighted to welcome additional treatments and options for people impacted by CIDP. 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. 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.”