Challenge AstraZeneca's first new category of complement drug Aspaveli in more than ten years to obtain approval!

Compilenewborn

On December 15th, Apellis Pharmaceuticals and Swedish Orphan Biovitrum (SOBI) jointly announced that the European Commission has approved Aspaveli (pegcetacoplan) for the treatment of episodes of anemia after receiving complement C5 inhibitors for at least 3 months.

Pegcetacoplan is the first and only therapy targeting complement C3 to receive regulatory approval

Pegcetacoplan represents the first new category of complement drugs approved by the regulatory authorities in more than a decade, and has the potential to improve the standard of care for PNH patients

PNH is a rare, chronic, and life-threatening blood disease.

This approval is based on the results of the head-to-head phase 3 study of PEGASUS

Pegcetacoplan is a targeted complement C3 inhibitor, C3 is the upstream signaling molecule of C5

Soliris and Ultomiris are two complement C5 inhibitors sold by Alexion.

In December 2020, AstraZeneca announced that it would acquire Alexion for $39 billion in cash and stock

Reference source: Apellis and Sobi Announce EU Approval of Aspaveli® (pegcetacoplan) for Treatment of PNH