ARIA The news that made this pop imo is likely to have legs, since the gap was caused by the same drug being pulled.
10:10AM Ariad Pharm announces U.S. resumption of marketing and commercial distribution of Iclusig (ponatinib) in refractory Philadelphia-positive leukemias (ARIA) 6.31 +0.79 : Co announced that the FDA has approved revised U.S. Prescribing Information (USPI) and a Risk Evaluation and Mitigation Strategy (REMS) for Iclusig (ponatinib) that allows immediate resumption of its marketing and commercial distribution. The USPI includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers. Iclusig is now indicated for the treatment of adult patients with:
T315I-positive chronic myeloid leukemia (chronic phase, accelerated phase, or blast phase) or T315I-positive Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia, and
Chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ acute lymphoblastic leukemia for whom no other tyrosine-kinase inhibitor therapy is indicated.
The FDA granted approval of the revised USPI based on its review of the Iclusig clinical-trial data, including 24-month follow up of the pivotal PACE trial. The boxed warning has been revised to alert patients and healthcare professionals to the risk of vascular occlusive events and includes a new warning for heart failure. The starting dose of Iclusig remains 45 mg daily.
At the end of October 2013, there were approximately 640 patients receiving Iclusig obtained through commercial channels in the U.S. Since then, Iclusig has been made available through emergency and single-patient investigational new drug (IND) applications, which were reviewed and approved by the FDA on a case-by-case basis. Through today, FDA has approved 350 INDs. This figure includes approximately 260 patients who have already received Iclusig and approximately 90 additional patients who have been approved to receive Iclusig through these mechanisms.
ARIAD management will host a conference call and webcast to discuss the approval of a new U.S. product label for Iclusig today, December 20 at 11:30 a.m. ET.
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