Ariad’s Inclusig Being Investigated by U.S. Regulators

The safety of Ariad Pharmaceuticals Inc.’s leukemia drug Iclusig is being investigated by U.S. regulators because of the increasing frequency of reports of serious blood clots and narrowing of blood vessels in patients.

“Health-care professionals should consider for each patient, whether the benefits of Iclusig treatment are likely to exceed the risks of treatment,” the U.S. Food and Drug Administration said today in a safety announcement. The agency urged doctors and patients to report side effects of the drug.

Ariad plunged a record 66 percent on Oct. 9 after the Cambridge, Massachusetts-based company said the FDA had placed a hold on enrollment of all trials of Iclusig because of safety issues among participants. The medicine was approved last year for two rare forms of leukemia, and will remain on the market, the company said.

“Any investor looking at buying this stock generally needs to be comfortable with this volatility and have at least a 1-plus year outlook,” Michael Yee, an analyst with RBC Capital Markets, wrote today in a research note. “Short-term sales of Iclusig could clearly slow due to new safety communication.”

Ariad declined 21 percent to $4.26 at the close in New York, the stock’s lowest value since December 2010. The shares have lost 78 percent this year.

Accelerated Approval

Iclusig was approved based on an accelerated process that relied on a single trial showing the drug helped patients. Companies that gain accelerated approval must conduct additional study to prove their drug is effective. Iclusig, Ariad’s sole approved drug, drew $14 million in sales in the second quarter.

Patients taking the drug have had side effects including fatal heart attacks, stroke and narrowing of large arteries of the brain and blood vessels in the extremities, the FDA said today, citing data from trials and reports since the drug entered the market.

Studies conducted before approval showed that serious blood clots in the arteries occurred in 8 percent of patients treated with the drug, and blood clots in the veins occurred in 3 percent. The most recent clinical data from the company showed at least 20 percent of those taking Iclusig have developed clots of narrowing of the blood vessels, the FDA said.

Before it's here, it's on the Bloomberg Terminal.