The FDA’s decision wasn’t surprising to analysts, as “deficiencies” in an approval application have become somewhat of a prelude to rejection. This year alone saw two other drugmakers, Provention Bio and Acadia Pharmaceuticals, receive negative feedback about their applications shortly before the FDA turned them down.
For Ardelyx, the path forward revolves around a new clinical trial. The company said it intends to request a meeting with the FDA “as soon as possible” to go over the rejection and what would be needed to gain approval.
