Shots:

• The approval is based on P-III HERCULES study results assessing Cablivi + plasma exchange and immunosuppressive therapy vs PBO (plasma exchange and immunosuppressive therapy) in 145 adults with aTTP
• P-III study results: reduction on a composite endpoint of aTTP-related death (12.7% vs 49.3%); aTTP recurrences (13% vs 38%); no deaths reported
• Cablivi (caplacizumab-yhdp) is an anti-vWF Nanobody- has received FDA’s FT designation and will be available in the US in H1’19. In 2018- Sanofi in-licensed Cablivi from Ablyn

Ref: Sanofi | Image: Chemistry World