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
Recombinant, XEMBIFY, and Yimmugo. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Recombinant Polyclonal - FDA Regulatory Timeline and 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.
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XEMBIFY - FDA Regulatory Timeline and 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 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.
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Yimmugo - FDA Regulatory Timeline and Events
Yimmugo is a drug developed by Grifols for the following indication: To treat primary immunodeficiencies (PID).
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Yimmugo
- Announced Date:
- June 17, 2024
- Indication:
- To treat primary immunodeficiencies (PID).
Announcement
Grifols announced that Biotest, a Grifols Group company, has received approval from the United States Food and Drug Administration (FDA) for Yimmugo®, an innovative intravenous immunoglobulin (Ig) therapeutic, to treat primary immunodeficiencies (PID).
AI Summary
Grifols announced that Biotest, a Grifols Group company, has received FDA approval for Yimmugo®, a new intravenous immunoglobulin (Ig) therapeutic designed to treat primary immunodeficiencies (PID). This marks Biotest’s first FDA-approved medicine and highlights their innovative approach to producing plasma-derived treatments.
Yimmugo is made using an advanced process at Biotest’s FDA-certified ‘Next Level’ facility in Germany. Already approved in Europe, the U.S. approval paves the way for the medicine’s launch later this year and further supports Grifols’ strategy to expand its portfolio. The addition of Yimmugo reinforces the company’s commitment to providing effective treatment options for patients with immune deficiencies, and it is expected to play a key role in Grifols’ future growth and revenue expansion.
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