This section highlights FDA-related milestones and regulatory updates for drugs developed by Grifols (GRFS).
Over the past two years, Grifols has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
XEMBIFY and Recombinant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
XEMBIFY FDA Regulatory Events
XEMBIFY is a drug developed by Grifols for the following indication: To include treatment-naïve patients with primary humoral immunodeficiencies (PI).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- XEMBIFY
- Announced Date:
- July 16, 2026
- Indication:
- To include treatment-naïve patients with primary humoral immunodeficiencies (PI).
Announcement
Grifols announced that the first patients have been dosed in two separate Phase 3 trials aiming to expand the U.S. labels for its signature immunoglobulin therapeutics, GAMUNEX®-C, an intravenous immunoglobulin (IVIg), and XEMBIFY®, its subcutaneous immunoglobulin (SCIg).
AI Summary
Grifols said the first patients have been dosed in two Phase 3 trials designed to expand the U.S. labels for its immunoglobulin products, GAMUNEX-C and XEMBIFY. One study, called SIGMA, is testing GAMUNEX-C in people with blood cancers such as chronic lymphocytic leukemia, multiple myeloma, and non-Hodgkin lymphoma who also have low antibody levels. The goal is to show the treatment can help prevent serious bacterial infections. The second study, XPERT, is evaluating XEMBIFY as a maintenance treatment for patients with chronic inflammatory demyelinating polyneuropathy, or CIDP, comparing it with GAMUNEX-C.
Grifols said these trials could give patients more treatment options and more flexibility, including intravenous and subcutaneous choices. The company noted that demand for its immunoglobulin products remains strong and that XEMBIFY has seen especially fast growth. Both studies are part of Grifols’ effort to broaden the use of its plasma-derived therapies and support patients with serious immune-related conditions.
Read Announcement- Drug:
- XEMBIFY
- Announced Date:
- July 29, 2024
- Indication:
- To include treatment-naïve patients with primary humoral immunodeficiencies (PI).
Announcement
Grifols announced that the United States Food and Drug Administration (FDA) has approved an expanded label for XEMBIFY®, the company's 20% subcutaneous immunoglobulin (SCIg), to include treatment-naïve patients with primary humoral immunodeficiencies (PI).
AI Summary
Grifols announced that the US FDA has approved an expanded label for XEMBIFY®, making it the first 20% subcutaneous immunoglobulin (SCIg) with dosing approved for treatment-naïve patients with primary humoral immunodeficiencies (PI). With this new approval, patients can start treatment directly with subcutaneous delivery instead of having to begin with an intravenous infusion.
The updated label also introduces a convenient biweekly dosing option. This change is supported by phase 4 clinical trial data, which showed that biweekly dosing maintained total Ig levels comparable to weekly administration. This approval is part of Grifols’ effort to provide flexible treatment options and to better address the evolving needs of patients with PI. The new label is expected to be launched in the United States in the third quarter of 2024.
Read Announcement
Recombinant Polyclonal FDA Regulatory Events
Recombinant Polyclonal is a drug developed by Grifols for the following indication: For HBV Treatment.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Recombinant Polyclonal
- Announced Date:
- November 19, 2024
- Indication:
- For HBV Treatment
Announcement
GigaGen Inc., announced hat the first patient has been dosed in a Phase 1 clinical trial evaluating the safety and tolerability of the first recombinant polyclonal drug candidate, GIGA-2339, for the treatment of hepatitis B virus (HBV) infection.
Read Announcement- Drug:
- Recombinant Polyclonal
- Announced Date:
- July 31, 2024
- Indication:
- For HBV Treatment
Announcement
GigaGen Inc a subsidiary of Grifols, announced today that the United States Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1 trial to evaluate the company's first recombinant polyclonal drug for the treatment of hepatitis B virus (HBV) infection, GIGA-2339.
AI Summary
GigaGen Inc., a subsidiary of Grifols, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application. This approval allows GigaGen to start a Phase 1 clinical trial of GIGA-2339 in late 2024. GIGA-2339 is the company’s first recombinant polyclonal antibody drug designed to treat hepatitis B virus (HBV) infection. The drug features over 1,000 fully human anti-HBV antibodies and is developed using an advanced technology platform that reproduces the human body’s natural immune response to HBV. This innovative approach aims to neutralize the virus and clear its DNA and antigens, offering potential for a functional cure for chronic HBV patients. The trial will focus on assessing the safety and tolerability of GIGA-2339 in people with confirmed HBV infection.
Read Announcement
