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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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| 20 December 2013 | By Alexander Gaffney, RAC
Months after forcing Ariad Pharmaceuticals to pull its leukemia drug Iclusig (ponatib) off the market following the discovery of serious safety risks, the US Food and Drug Administration (FDA) has said it will allow the company to resume marketing the drug to a restricted population.
FDA had launched an investigation into Iclusig in October 2013 following reports of life-threatening blood clots and severe narrowing of blood vessels.
"Currently, approximately 24 percent of patients (nearly 1 out of 4) in the Phase 2 clinical trial (median treatment duration 1.3 years) and approximately 48 percent of patients in the Phase 1 clinical trial (median treatment duration 2.7 years) have experienced serious adverse vascular events, including fatal and life-threatening heart attack, stroke, loss of blood flow to the extremities resulting in tissue death, and severe narrowing of blood vessels in the extremities, heart, and brain requiring urgent surgical procedures to restore blood flow," FDA said in a statement.
At the time, FDA said it was possible that some populations of leukemia patients might benefit from the drug, but ultimately concluded that Ariad should withdraw the drug until such time as FDA felt that it was proper to resume marketing.
FDA left in place the opportunity for patients to obtain the drug through expanded access investigational new drug (IND) applications, which require a drug to be administered with the consent of Ariad and under the direct supervision of a doctor.
Weeks earlier, Ariad had also pulled the plug on a Phase III clinical trial assessing the drug's efficacy and safety in chronic myeloid leukemia patients (CML) after FDA raised concerns about the same thrombotic events.
But now, a little more than a month later, FDA has walked back at least some of its concerns about the drug, saying that the company can resume marketing it to certain populations in which the drug's benefits outweigh its still-significant risks.
FDA said it will require "several new safety measures" for the drug, including label changes to reflect a narrower intended patient population, new warnings and precautions, new dosing recommendations, an updated medication guide and-most significant of all-a formal Risk Evaluation and Mitigation Strategy (REMS) plan for the drug.
In addition, FDA said Ariad would be required to conduct several postmarketing safety studies on the drug to better assess its risks and the appropriate dose levels at which benefits can be maximized relative to risks.
In a statement, Ariad said it was pleased to be able to resume marketing operations for the drug.
"In less than two months of suspending marketing and commercial distribution of Iclusig in the US, we addressed the issues raised by the FDA and now are able to market and distribute Iclusig again in the US," said Harvey Berger, chairman and chief executive officer of Ariad. "As we look ahead to re-launching Iclusig in the US and fulfilling our post-marketing requirements, we will continue to focus on understanding the benefits and risks of Iclusig treatment in patients with resistant or intolerant Philadelphia-positive leukemias."
Ariad said it had maintained access to the drug throughout the interruption in marketing through 350 INDs, roughly half of its prior patient access.
FDA Statement
Ariad Statement