Seven weeks after Ariad Pharmaceuticals Inc. was forced to halt US sales of its leukemia drug, the Cambridge biotechnology company said Friday that it has won regulatory approval to resume selling the medicine with a more restrictive label and updated safety information.
Food and Drug Administration officials approved the drug, called Iclusig, for a narrower set of patients suffering from two forms of blood cancer—chronic myeloid leukemia and Philadelphia chromosome positive acuse lymphoblastic leukemia—for whom other treatments aren’t working. But those patients must determine, with their doctors, whether the benefits from the powerful Ariad drug outweigh the risks of life-threatening blood clots and heart problems.
Ariad shares were up 13.4 percent in late morning trading.
The new label “puts in the hands of the prescribing physician the choice as to the utilization of Iclusig,” Ariad chief executive Harvey J. Berger said in an interview. “Physicians who know the patients and know the severity of the leukemia and whether the patients have preexisting conditions like heart attack or stroke can take all of that into consideration.”
Clinical trial data that emerged after Iclusig was approved in the US market late last year showed greater safety risks than were previously known. Those risks were highlighted in an Oct. 31 drug safety communications from the FDA that prompted Ariad to stop marketing Iclusig in the United States. Ariad executives have been in active discussions with FDA regulators since then to find a way to return the drug to market. It has remained on the market in Europe, but regulators there have required that the new safety information be conveyed to doctors and patients.
The quick resolution with the FDA was “remarkable,” Berger said. “We worked very hard with the FDA to define the patient population, agree on the risk profile and bring the drug back in very short order to patients for whom it’s an appropriate or indicated therapy.”
Berger said he expected commercial sales of Iclusig would resume during the first two weeks of January. About 640 patient were taking Iclusig in the United States at the time of the sales suspension, he said, and 350 were approved by the FDA to continue taking it under an arrangement worked out between their doctors and regulators during the label negotiations.
Ariad executives in September said they expected about 2,500 US patients would switch to Iclusig from other, less effective therapies.
“Going forward, we expect the market is narrow than 2,500,” said Berger, but he declined to be more specific.
Berger said Ariad executives would likely offer fresh market guidance at the annual J.P. Morgan Healthcare Conference next month.
Berger also said the resumption of sales means Ariad is likely to rehire dozens of salespeople and medical liaisons let go when the drug was pulled from the commercial market. But the number of hires would be significantly less than the 160 workers idled last month, he said.
“We think we can make this a cash flow positive commercial operation with fewer people,” he said.
Berger also said Ariad would decide in the first quarter of 2014 whether to move forward with plans to occupy a new headquarters complex under construction in Kendall Square and, if so, how much space the company is now likely to need.