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.
Jan. 18, 2022 /PRNewswire/ --
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
"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.
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
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
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.