Apellis has posted a notice on HRSA's website informing 340B entities how they can get 340B pricing on the company's new product, Empaveli, which has a REMS.

Biopharma Company Apellis Posts 340B Limited Distribution Notice

Biopharmaceutical company Apellis has announced a limited distribution plan for Empaveli (pegcetacoplan), a newly approved treatment for adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare, chronic, life-threatening blood disorder.

The U.S. Food and Drug Administration (FDA) approved Empaveli on May 14. It is available only through a Risk Evaluation and Mitigation Strategy (REMS).

The U.S. Health Resources and Services Administration (HRSA) recently posted on its website a notice to 340B covered entities from Apellis informing them how they can buy Empaveli at its 340B ceiling price. They can apply for admission to Apellis’ closed pharmacy network for Empaveli. Or, if they have a 340B contract pharmacy arrangement with PantherRx, they can place bill to/ship orders through Cardinal Health.

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