The Food and Drug Administration is nearing a decision on the first treatment for geographic atrophy, a progressive eye disease and a leading cause of blindness in older people. Apellis Pharmaceuticals, the drug’s maker, has expressed public confidence in the data supporting approval. Investors are more divided.
The agency has until Feb. 26 to issue a ruling on the Apellis drug, three months longer than originally anticipated. The extended review — along with the FDA’s decision to not convene an advisory panel of outside experts — are central to the approval controversy. So, too, is the January announcement by Apellis’ longtime chief medical officer that he would be departing the company.
Here are six things to know — or ponder — about the Apellis drug, called pegcetacoplan, its blockbuster commercial potential, and the series of unusual events that have generated spirited debate as the FDA’s decision nears.
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