FDA Grants Type B Pre-IND Meeting for RTX-NP (MabionCD20) in Immune Thrombocytopenia
核心洞察
The U.S. FDA granted a Type B pre-IND meeting for RTX-NP (搜索) (MabionCD20), a rituximab product developed jointly by Oddifact SAS (搜索) and Mabion S.A. (搜索) for adult patients with persistent or chronic primary immune thrombocytopenia (搜索) (ITP).
The meeting, classified under the Division of Nonmalignant Hematology, enables the companies to align with the FDA on development and regulatory questions ahead of a potential Biologics License Application (BLA) submission.
RTX-NP (搜索) holds FDA Orphan Drug Designation and aims to establish the first formal, regulatory-backed rituximab treatment option for ITP patients who have insufficient response, relapse, or dependence after first-line therapy.
Oddifact SAS (搜索), a French rare disease TechDev company, and Mabion S.A. (搜索) (WSE: MAB), a Polish biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted a Type B pre-IND meeting for RTX-NP (搜索) (MabionCD20), a rituximab product developed jointly for the treatment of adult patients with persistent or chronic primary immune thrombocytopenia (搜索) (ITP) who have had an insufficient response, relapse, or dependence after first-line therapy.
The FDA opened a Pre-IND file (PIND 183961) under Oddifact's name and classified the request as a Type B meeting — the most substantive category of FDA pre-IND interactions — engaging the Division of Nonmalignant Hematology. The meeting will enable both companies to align with the Agency on critical development questions.
A Regulatory Path Toward First Formal Approval
ITP is a rare autoimmune disorder characterized by abnormally low platelet counts. Despite its well-documented clinical activity in ITP, rituximab has never received formal FDA approval for this indication. RTX-NP (搜索) — which benefits from an FDA Orphan Drug Designation — aims to bridge this gap and provide patients and physicians with a validated, regulatory-backed treatment option.
MabionCD20 completed its Phase 3 clinical trials in January and February 2023, while RTX-NP (搜索) has received FDA Orphan Drug Designation. The companies said the FDA meeting represents an important milestone toward finalizing the development strategy and potential Biologics License Application (BLA) submission for RTX-NP.
Leadership Perspectives
"The FDA's decision to grant us a Type B pre-IND meeting for RTX-NP (搜索) highlights the work accomplished by Oddifact and Mabion. This represents an important milestone to finalize our path to BLA submission and bring a meaningful treatment option to ITP patients who still lack adequate options after first-line therapy," said Pierre-Alexandre Teulié, Chief Executive Officer, Oddifact SAS (搜索).
"The FDA's decision marks an important step in advancing MabionCD20 from a well-characterized biologic asset toward a potential innovative treatment for patients with rare diseases. Our collaboration with Oddifact brings together Mabion's expertise in monoclonal antibody development and manufacturing with Oddifact's experience in rare diseases and indication repurposing, creating a strong foundation for advancing RTX-NP (搜索) toward clinical development and, ultimately, the U.S. market," said Gregor Kawaletz, Chief Executive Officer, Mabion S.A. (搜索)
Collaboration and Company Profiles
The collaboration combines Mabion's expertise in monoclonal antibody development and manufacturing with Oddifact's experience in rare diseases and indication repurposing, with the companies aiming to advance RTX-NP (搜索) toward clinical development and potential commercialization in the U.S.
Oddifact is a French rare disease TechDev company leveraging its AI-enabled platform (S.A.V.E.) to identify and develop off-label orphan opportunities. Oddifact has secured 15 FDA Orphan Drug Designations to date. Mabion S.A. (搜索) is a Polish biotechnology company specializing in the development and manufacturing of monoclonal antibody biologics.