Inebilizumab-cdon: USFDA Approved for the Treatment of NMOSD (Neuromyelitis Optica Spectrum Disorder)
| Autor: | Faraat Ali, Varisha Anjum, Kamna Sharma, Asad Ali |
|---|---|
| Rok vydání: | 2022 |
| Předmět: |
Aquaporin 4
Oncology Antibody-dependent cell-mediated cytotoxicity medicine.medical_specialty Neuromyelitis optica United States Food and Drug Administration business.industry Neuromyelitis Optica Antibodies Monoclonal Humanized Humanized antibody medicine.disease United States Food and drug administration Clinical trial Inebilizumab Internal medicine Drug Discovery Humans Biologics License Application Medicine Spectrum disorder business |
| Zdroj: | Current Drug Discovery Technologies. 19 |
| ISSN: | 1570-1638 |
| DOI: | 10.2174/1570163818666210519103001 |
| Popis: | Inebilizumab-cdon (Uplizna™) was currently approved by the United States Food and Drug Administration (USFDA) for the treatment of NMOSD (neuromyelitis optica spectrum disorder). It was developed by Viela Bio (Nasdaq: VIE) USA. Inebilizumab-cdon (formerly MEDI-551) is a humanized antibody, which induces CD19 + B cell depletion by increasing antibody-dependent cell cytotoxicity (ADCC) and cell phagocytosis (ADCP) of effector cells. Various clinical trials exhibit its safe and effective pharmacokinetic and pharmacodynamic profile. In June 2019, Viela Bio submitted Biologics License Application (BLA) to the FDA based on the findings obtained from the N-Momentum trial. This article summarizes the milestones in the development of Inebilizumab-cdon leading to this approval for the treatment of advanced NMOSD. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|