Grifols is introducing 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, or 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,” the company said.
Xembify was approved by the 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, the company said.
“Today marks an exciting milestone as we launch Xembify, an important new medicine for PI patients in the United States,” said Joel Abelson Bioscience commercial division president. “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,” John Boyle, Immune Deficiency Foundation president and CEO said. “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.