Analysts in March foresaw Incyte's ($INCY) Jakafi easily topping the blockbuster mark when it met its goals in a Phase II trial in certain patients with a rare type of bone marrow disease. Now, with the FDA's official green light, it's time for Incyte to get working on turning those predictions into reality.
The orphan drug, known as Jakavi outside the U.S. where Novartis ($NVS) has full commercialization rights, Thursday became the first treatment to win the FDA's go-ahead to treat patients with polycythemia vera, a chronic condition marked by the overproduction of red blood cells.
U.S. regulators based the blessing on a Phase III trial that saw the med reduce both spleen size in patients and the need for phlebotomies to control the disease, according to Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "The approval of Jakafi for polycythemia vera underscores the importance of developing drugs matched to our increasing knowledge of the mechanisms of diseases," he said in a statement.
Those trial results had analysts crying "blockbuster" nearly 9 months ago when Novartis announced it would this year be using them as a basis for regulatory filings around the globe. Vontobel analyst Andrew Weiss told Reuters at the time that he predicts the drug will bring in 500 million Swiss francs ($567 million) per year for each indication Novartis can add to the drug's label.
The Swiss pharma giant is also testing Jakavi, initially approved to treat blood cancer myelofibrosis, in pancreatic cancer and other advanced malignancies.
- read the release
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