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FDA Approves Expanded Label for Grifols' Xembify, Allowing Treatment-Naïve PI Patients Subcutaneous Immunoglobulin Therapy

• The FDA has approved an expanded label for Grifols' Xembify, a 20% subcutaneous immunoglobulin, to include treatment-naïve patients with primary humoral immunodeficiencies (PI). • Xembify is the first 20% SCIg with this extended label, which eliminates the need for initial intravenous treatment for patients starting SCIg therapy. • The approval also includes biweekly dosing, supported by phase 4 clinical trial data demonstrating non-inferiority in total Ig levels compared to weekly dosing. • Grifols plans to launch the new label in the U.S. in Q3 2024, offering patients greater convenience and flexibility with biweekly dosing.

The U.S. Food and Drug Administration (FDA) has approved an expanded label for Xembify (immune globulin subcutaneous human-klhw), a 20% subcutaneous immunoglobulin (SCIg) manufactured by Grifols, to include treatment-naïve patients with primary humoral immunodeficiencies (PI). This approval marks Xembify as the first 20% SCIg that allows patients to begin SCIg therapy without prior intravenous administration, offering a significant advantage in patient convenience and treatment initiation.
The FDA's decision on the Supplemental Biologics Application (sBLA) also incorporates biweekly dosing, a feature supported by data from a phase 4 clinical trial (NCT04566692). The trial, a multicenter, single-sequence, open-label study across 18 U.S. sites involving 27 subjects, demonstrated that biweekly Xembify administration achieved non-inferiority in total Ig levels compared to weekly administration. According to Grifols Chief Scientific Innovation Officer, Joerg Schuettrumpf, this eliminates the need for patients to have initial intravenous treatment, differentiates Xembify from other SCIg therapies, and offers patients greater convenience and flexibility with biweekly dosing.
The phase 4 trial revealed no unique safety concerns, with tolerability profiles consistent between biweekly and weekly administration. The primary endpoint was successfully met, affirming the efficacy of biweekly dosing in maintaining adequate immunoglobulin levels in PI patients.

Market and Strategic Implications

Grifols intends to launch the updated Xembify label in the U.S. during the third quarter of 2024. This expansion aligns with Grifols' broader strategy to increase its presence in the immunoglobulin market, which is projected to experience high single-digit growth due to the rising prevalence of PI and secondary immunodeficiencies (SID). Immunodeficiency treatments are expected to be a major driver of this growth, accounting for up to 55% of the total Ig market.

About Xembify

Xembify is a 20% solution of purified human immunoglobulin, primarily IgG, derived from large pools of human plasma. It is indicated for the treatment of PI in patients aged two years and older and is administered subcutaneously. In addition to the U.S., Xembify is also approved for PI and select SID in Europe, Canada, and Australia, with biweekly dosing already available in several European markets.

Safety Information

Xembify carries a warning for potential thrombosis, with risk factors including advanced age, prolonged immobilization, and cardiovascular risk factors. The prescribing information advises administering Xembify at the minimum dose and infusion rate practicable for at-risk patients, ensuring adequate hydration, and monitoring for signs of thrombosis. Other warnings and precautions include the risk of aseptic meningitis syndrome (AMS), hypersensitivity reactions, renal dysfunction/failure, hemolysis, and transfusion-related acute lung injury (TRALI).
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Reference News

[1]
Grifols Receives Approval for Expanded Xembify (immune globulin subcutaneous human-klhw) Label in U.S.
drugs.com · Jul 29, 2024

Grifols' Xembify®, a 20% subcutaneous immunoglobulin, received FDA approval for an expanded label to include treatment-n...

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