Company: AZN
Filing Date: 2025-11-06
Form Type: 6-K
Source: 0001654954-25-012630
Chunk: 8

Company: ASTRAZENECA PLC
Filing Date: 2025-11-06
Form: 6-K
Chunk 8
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 controlled                     
 CRSwNP.                                                             |

Rare Disease

Alexion, AstraZeneca Rare Disease, delivered 18 presentations, including four oral presentations, from its leading rare neurology portfolio at the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and the Myasthenia Gravis Foundation of America (MGFA) Scientific Session in San Francisco, California.

Koselugo

| Approval 
 Japan    | KOMET          
 August 2025    | ∗For the                                                            
 treatment of adult patients with symptomatic, inoperable plexiform  
 neurofibromas in neurofibromatosis type 1.                          |
| Approval 
 EU       | KOMET          
 October 2025   | ∗For the                                                            
 treatment of adult patients with symptomatic, inoperable plexiform  
 neurofibromas in neurofibromatosis type 1.                          |
| Approval 
 Japan    | SPRINKLE       
 September 2025 | ∗Granule                                                            
 formulation for paediatric patients one year of age and older with  
 neurofibromatosis type 1 who have symptomatic, inoperable plexiform 
 neurofibromas.                                                      |
| Approval 
 US       | SPRINKLE       
 September 2025 | ∗Granule                                                            
 formulation for paediatric patients one year of age and older with  
 neurofibromatosis type 1 who have symptomatic, inoperable plexiform 
 neurofibromas.                                                      |

Ultomiris

| Approval 
 China    | CHAMPION-NMOSD 
 August 2025    | ∗For the                                                       
 treatment of adult patients with neuromyelitis optica spectrum 
 disorder who are anti-aquaporin-4 antibody                     
 positive.                                                      |

gefurulimab

| Data presentation 
 AANEM/MGFA        | PREVAIL      
 October 2025 | ∗Positive results from the PREVAIL Phase III                       
 trial demonstrated an improvement from baseline in MG-ADL total    
 score at week 26 compared to placebo (treatment difference: -1.6   
 [95% CI: -2.4, -0.8], p<0.0001). A clinically meaningful           
 improvement was observed as early as week one, and was sustained   
 through week 26. Additionally, a clinically meaningful improvement 
 in key secondary endpoint, QMG total score, was seen as early as   
 week four