Grifols Expands U.S. XEMBIFY® Label, Boosting Ig Portfolio

Grifols, a leading producer of plasma-derived medicines, recently announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for XEMBIFY®, the company's 20% subcutaneous immunoglobulin (SCIg) solution. This approval now includes treatment-naïve patients with primary humoral immunodeficiencies (PI), making XEMBIFY the first and only 20% SCIg that allows patients to begin treatment without prior intravenous therapy. The expanded label also includes the option for biweekly dosing.

This significant development follows the results of a phase 4 clinical trial (NCT04566692), which demonstrated that patients treated with XEMBIFY every two weeks achieved comparable total immunoglobulin (Ig) levels to those treated weekly. The trial, which included 27 subjects across 18 U.S. sites, identified no unique safety issues, and the tolerability profiles were consistent between biweekly and weekly administrations.

The approval marks a milestone in Grifols' broader strategy to increase the adoption of XEMBIFY, which is expected to see growth in the global immunoglobulin market. This market is projected to grow in the high single digits in the coming years, driven primarily by the increase in both primary and secondary immunodeficiencies. Together, these conditions account for nearly 55% of the total immunoglobulin market, with treatment for immunodeficiencies expected to outpace other indications.

Joerg Schuettrumpf, Grifols' Chief Scientific Innovation Officer, emphasized the benefits of the expanded label, stating, "The XEMBIFY label expansion eliminates the need for patients to have initial intravenous treatment, which differentiates XEMBIFY from other SCIg therapies. It offers patients greater convenience and flexibility with biweekly dosing." Grifols plans to launch the new label in the U.S. in the third quarter of 2024, reflecting the company's commitment to providing more options for patients and adapting to their needs and lifestyles.

In addition to the U.S., the biweekly dosing option for XEMBIFY is already available in various European markets, including the Czech Republic, France, Iceland, Norway, Slovakia, Spain, and Sweden. The company is also working to introduce XEMBIFY in other European countries. Currently, XEMBIFY is indicated for primary immunodeficiencies in the U.S. and for both primary immunodeficiencies and select secondary immunodeficiencies in Europe, Canada, and Australia.

Grifols has been a pioneer in the plasma industry since its founding in Barcelona in 1909. The company is dedicated to improving global health through the development of essential plasma-derived medicines and innovative healthcare services. Grifols operates the world's largest network of donation centers, with over 390 centers across North America, Europe, Africa, the Middle East, and China.

As a recognized leader in transfusion medicine, Grifols offers a comprehensive portfolio of solutions designed to enhance safety from donation to transfusion. The company also provides high-quality biological supplies for life-science research, clinical trials, and the manufacture of pharmaceutical and diagnostic products. With more than 24,000 employees in over 30 countries, Grifols remains committed to a sustainable business model that emphasizes continuous innovation, quality, safety, and ethical leadership.

The company’s class A shares are listed on the Spanish Stock Exchange as part of the Ibex-35, while its non-voting class B shares are listed on the Mercado Continuo and on the U.S. NASDAQ through ADRs.