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Alexion Gets Speedy Review For Soliris Successor

 
• By Kevin Grogan

Switching patients from the very expensive ultra rare disorder drug to ravulizumab will be a key strategy for Alexion if the latter is approved. Recent compelling data in paroxysmal nocturnal hemoglobinuria patients suggests the long-acting C5 complement inhibitor could offer more benefit than its predecessor with more convenient dosing.

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Alexion to pass Soliris baton to ravulizumab • Source: Shutterstock

Having just presented more strong data for ravulizumab, also known as ALXN1210, Alexion Pharmaceuticals Inc. is cashing in a priority review voucher (PRV) to get a faster assessment in the US for the successor to its blockbuster Soliris (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

The Biologics License Application to the FDA for the investigational long-acting C5 complement inhibitor has been made with a rare disease PRV, which means an expedited eight-month evaluation instead of the standard 12 months

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