Astellas’ loss is Apellis’ gain as FDA setback shakes up prospects

21 November 2024

Astellas Pharma (TYO: 4503) has been hit by bad news from the US Food and Drug Administration, which will not currently approve the firm’s request to supplement the label for Izervay (avacincaptad pegol).

The Japanese company sought to include two-year data from the Phase III GATHER2 trial in the drug’s prescribing information.

The FDA said the rejection was due to a "statistical matter" related to proposed labeling language and was unrelated to the safety or benefit/risk profile.

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