The six-week marketing suspension for Iclusig that caused Ariad to take some drastic measures in 2013 has not negatively affected how physicians view the drug for chronic myeloid leukemia (CML), according to a survey by the firm Jefferies.
Analyst Eun Yang wrote in a May 2 research note that the impact of the temporary suspension and the reintroduction with a more restricted label “minimally impacted” doctors’ Iclusig use, and that around 86% of the 50 polled hematologists/oncologists “noted their overall view of Iclusig is unchanged. Iclusig is indicated for CML and Philadelphia-chromosome-positive acute lymphoblastic leukemia.
Ariad suspended distribution and marketing of the drug in October 2013 because of FDA concerns about blood clots found in clinical trial patients. The FDA approved the drug in December 2012 while studies were still ongoing, and CEO Harvey Berger noted at the time of the withdrawal that the FDA’s perspective on the data had changed, but that the data was the same data that led to the 2012 approval.
Berger anticipated the suspension would result in a more restricted label. The drug returned to market in January.
For more on Ariad’s Iclusig relaunch, as well as how other small biotech companies view the unique commercial challenges and opportunities of bringing novel products to market, please read Leadership Exchange: Small Size, Big Prize, from the May 2014 issue of MM&M.
