- XEMBIFY®, Grifols’ first 20% subcutaneous immunoglobulin for Primary Immunodeficiency (PI) treatment, is now available in the U.S.
- With proven safety, efficacy and tolerability, XEMBIFY® is formulated for a wide range of PI patient types, including those with risk factors
- In addition to the U.S. launch of XEMBIFY®, the company is working to obtain additional approvals in Canada, Europe and other global markets
Barcelona, December 12, 2019- Grifols (MCE:GRF, MCE:GRF.P NASDAQ:GRFS), a leading global producer of plasma-derived medicines, today announced the launch of its latest immunoglobulin (IG) innovation, XEMBIFY® (immune globulin subcutaneous human-klhw), the company’s first 20% subcutaneous immunoglobulin therapy for the treatment of patients 2 years of age and older with primary immunodeficiency (PI).
With proven safety, efficacy, and tolerability, XEMBIFY® offers subcutaneous administration to patients in the treatment of PI, which are rare and chronic genetic disorders that occur in people born with an impaired or absent immune system. There are roughly 150,0001 patients with PI who may be appropriate for IG therapy.
Strengthening Grifols’ growing IG portfolio for PI treatment, XEMBIFY® features a balanced formulation for the treatment of a wide range of PI patients, inclusive of those with risk factors, such as diabetes or cardiac impairment. XEMBIFY® was approved by the U.S. Food and Drug Administration (FDA) in July 2019.
With maximum immunoglobulin G (IgG) potency and purity due to the unique caprylate/chromatography process, XEMBIFY® provides a customizable IG treatment option (from weekly to daily) that offers patients reliable protection from infections.
“Today marks an exciting milestone as we launch XEMBIFY®, an important new medicine for PI patients in the United States,” said Joel Abelson, President, Bioscience Commercial Division. “Adding to our existing IG portfolio, XEMBIFY® is another example of Grifols executing on our mission to improve the lives and well-being of people who suffer from serious, rare and chronic diseases.”
“People living with PI benefit from having a number of different treatment and dosing options, ultimately giving them an opportunity to tailor treatment to meet their specific needs,” said John G. Boyle, President and Chief Executive Officer of the Immune Deficiency Foundation. “Adding XEMBIFY® to the list of available treatments for PI will give members of our community greater flexibility in managing their care and reducing the impact PI has on their lives.”
XEMBIFY® will be made available to patients and healthcare professionals through a distribution network that includes the following providers: Advanced InfusionCare, Nufactor a specialty infusion company, CVS/Specialty, Optum Infusion Services, and Accredo.
The launch of XEMBIFY® solidifies Grifols as a frontrunner in disease treatment with immunoglobulins and reflects the company’s commitment to R+D+i, which has enabled the company to further expand its industry-leading portfolio of plasma-derived medicines to benefit patients and healthcare professionals. The company is currently working with healthcare authorities to obtain approval for XEMBIFY® in Canada, Europe and other global markets.
The most common adverse reactions in ≥5% of subjects in the clinical trial were local adverse reactions, including infusion-site erythema (redness), infusion-site pain, infusion-site swelling (puffiness), infusion- site bruising, infusion-site nodule, infusion-site pruritus (itching), infusion-site induration (firmness), infusion-site scab, infusion-site edema, and systemic reactions including cough and diarrhea.
1Kobrynski L, Powell RW, Bowen S. Prevalence and morbidity of primary immunodeficiency diseases, United States 2001-2007. J Clin Immunol. 2014 Nov;34(8):954-61. doi: 10.1007/s10875-014-0102-8. Epub 2014 Sep 26.