European authorities expand the indication for cutaquig® for patients with secondary immunodeficiencies

Octapharma announced today that the indication for cutaquig®, a human immunoglobulin for subcutaneous administration, has been expanded in the European Union (EU), providing more flexible treatment options to a far-wider range of patients with acquired immune deficiencies.

Secondary immunodeficiencies (SIDs) are a group of acquired diseases that cause full or partial impairment of the immune system, leaving patients at increased risk of severe and recurrent infections. For example, patients with a type of SID called secondary antibody deficiency suffer from impaired antibody production or function.

Immunoglobulin replacement therapy is a well-established treatment approach for patients with SIDs and effectively reduces the rate of infections in these patients. cutaquig® is a ready-to-use, liquid immunoglobulin product administered subcutaneously. The indication for cutaquig® in the EU has recently been expanded to cover patients with any type of SID who need immunoglobulin replacement therapy.

SIDs arise as a consequence of an underlying disease, condition, and/or as a side effect of treatment. They are seen in patients suffering from malnutrition or HIV infection, and in patients with haematological malignancies and a range of rheumatological and neurological diseases. Treatments associated with SIDs include stem cell or organ transplantation, steroids and immunosuppressive therapies, even newer agents such as CAR-T cell therapy.

The new extended indication for cutaquig® includes adults, children and adolescents who suffer from severe or recurrent infection, ineffective antimicrobial treatment and have either proven specific antibody failure or a serum immunoglobulin (IgG) level below 4 g/L. Previously, cutaquig® was only approved for patients with hypogammaglobulinaemia (i.e., low levels of serum IgG) secondary to chronic lymphocytic leukaemia, multiple myeloma or allogeneic haematopoietic stem cell transplantation.

“Severe and recurrent infections are a major complication in patients with diverse types of SID. The expanded indication for cutaquig® will offer more patients the option of a subcutaneous product to replenish immunoglobulin levels and reduce their risk of infection.” explains Dr Christoph Wissmann, VP and Head of IBU Immunotherapy at Octapharma.

Reflecting the need and benefit of individualising replacement immunoglobulin therapy, the updated label also allows increased flexibility in terms of the dosing frequency. Patients and providers now have the flexibility to administer cutaquig® at regular intervals from once a day to every other week. Patients who prefer less frequent injections have the option of receiving cutaquig® therapy every other week, whereas some patients may prefer more frequent therapy with smaller dosages.

“With the updated approval, we can personalise the frequency of subcutaneous therapy for our patients,” commented Olaf Walter, Board Member at Octapharma. “Aligning treatment with patients’ preferences and lifestyles has great potential for improving the lives of our patients.”

As part of the company’s continuous commitment to improving care for patients on immunoglobulin replacement therapy, Octapharma continues to conduct clinical trials investigating cutaquig® in patients with SIDs.

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs more than 9,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology, and Critical Care.

Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, and operates more than 160 plasma donation centres across Europe and the US.

About cutaquig®

cutaquig® (Subcutaneous Human Normal Immunoglobulin) is a 16.5% immune globulin solution for subcutaneous infusion indicated in Europe for the treatment of patients with primary immunodeficiency syndromes with impaired antibody production and secondary immunodeficiencies in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or serum IgG level of <4g/L.

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