The FDA has agreed to an accelerated review of Ariad Pharmaceuticals' (NASDAQ: ARIA) leukemia drug ponatinib, the company announced Wednesday. The FDA has established an action date of March 27, the company said.
The FDA accepted Ariad's request to launch a "priority review," which the FDA uses to shorten the review time for drugs that could provide significant improvements in treatment of diseases. Ponatinib is aimed at treating chronic myeloid leukemia and acute lymphoblastic leukemia, doing so by inhibiting an abnormality known as BCR-ABL.
Ponatinib will face competition from other leukemia drugs on the market, including products from Novartis (NVS 0.03%) and Bristol-Myers Squibb (BMY 0.87%). Competition and questions about approval spurred an analyst at Oppenheimer & Co. to downgrade Ariad earlier this week from "outperform" to "perform." The analyst also raised his price target to $23.
The Boston Globe quoted CEO Harvey Berger as saying: "We're launch-ready as we stand here today. Whenever the approval comes, we have the sales and distribution force, the manufacturing people, the medical liaisons, all the people we need to commercialize successfully."
