Ariad Pharmaceuticals Inc. (ARIA:US) rose the most in more than four years after European regulators allowed the company to continue selling its leukemia drug, which is suspended in the U.S. because of the treatment’s risks.
Ariad climbed 36 percent to $3.78 at the close in New York, the biggest single-day increase since July 2009.
The shares had plunged 44 percent on Oct. 31 after the U.S. Food and Drug Administration suspended sales pending a review. The agency found about 24 percent of patients using the drug in a trial had heart attacks, strokes and other serious vascular events. The European Medicines Agency today recommended patients with a history of heart attack or stroke stop using Iclusig unless the benefits outweigh the dangers and that possible new users be assessed for cardiovascular risks, Cambridge, Massachusetts-based Ariad said today in a statement.
“We have been working closely with the EMA to provide updated clinical-trial data on patients treated with Iclusig,” Jonathan Dickinson, general manager of Ariad in Europe, said in the statement.
The European regulators also recommended patients be monitored and that Iclusig be stopped if a user’s hypertension isn’t under control. The EMA plans to further review the benefits and risks of Iclusig and may make additional recommendations, Ariad said.
Iclusig is Ariad’s only product and was approved in July in Europe and last year in the U.S. for two rare blood cancers. The treatment is expected to generate revenue of $52 million next year, according to the average of nine analysts’ estimates (ARIA:US) compiled by Bloomberg.
In the U.S., the medicine was approved based on an accelerated process that relied on a single trial showing it helped patients. Companies that gain accelerated approval must conduct additional research to prove the medicine is effective. Those further results for Iclusig showed the increased safety risks.
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