US drugmaker Ariad Pharmaceutical (Nasdaq: ARIA) says it temporarily suspending the marketing and commercial distribution of Iclusig (ponatinib), its only marketed product, in the USA. The news saw the firm’s shares plunge 40% to $2.39 by mid-morning trading yesterday (October 31). The company’s shares had already fallen 79% prior to the latest news.
Iclusing, a treatment for patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL), has been the subject of a Food and Drug Administration investigation of an increasing frequency of reports of serious and life-threatening blood clots and severe narrowing of blood vessels of patients taking the drug (The Pharma Letter October 14). The suspension is being implemented while the company continues to negotiate updates to the US prescribing information for Iclusig and implementation of a risk mitigation strategy.
Working with FDA to resume marketing
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