Seven weeks after Ariad Pharmaceuticals Inc. was forced to halt US sales of its leukemia drug, prompting an outcry from patients and doctors, the Food and Drug Administration issued new safety measures Friday that will allow the Cambridge biotech to resume selling the medicine.
An agreement reached between the FDA and Ariad calls for a more restrictive drug label and updated information on safety risks, letting it market the powerful and expensive treatment to a narrower set of patients suffering from blood cancer. The target US market will now be only about 1,300 patients, slightly more than half the 2,500 Ariad projected before halting marketing on Nov. 1.
But because the drug, called Iclusig, will be priced above $115,000 a year per patient — slightly higher than competing leukemia therapies —- even the smaller patient population should be enough for Ariad to build a viable business, executives said. The company lost more than two-thirds of its market value and laid off 40 percent of its staff after suspending Iclusig sales.
Patients who say Iclusig combats their type of leukemia hepled convinced FDA officials to keep making Iclusig available during the suspension if their doctor had already been prescribing it. On Friday, many of them celebrated.
“I did a dance in my living room,” said Beth Galliart, a California investment firm employee who has been taking the drug in a clinical trial since 2009. “I would like to believe that feedback from patients helped the process. I think we are a reminder of what was at stake and also a reminder that many of us are on Iclusig without the serious adverse events.”
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