Dallas, Texas 01/02/2014 (FINANCIALSTRENDS) – Ariad Pharmaceuticals, Inc. (NASDAQ:ARIA), the 1.27 billion market-cap pharmaceutical which develops therapies with cell signalling with small molecules to treat cancer has since won FDA approval for its leukaemia drug – Iclusig (ponatinib). FDAs Christmas gift comes just-in time for the major pharmaceutical as Iclusig has been a major prospect for the company. FDA approval was possible only after revised USPI and REMS for Iclusig were announced.
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA),can following the approval by FDA, resume the marketing as well as commercial distribution of Iclusig.
In October last, Iclusig was suspended when FDA did not allow new patient enrolment for clinical trials, due to the high incidence of toxic in the vessels for PACE trails in patients demonstrating Chronic Myeloid Leukaemia. The initial hold later led to the temporary cessation in sales and marketing of the drug.
ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) can now market Iclusig but now the drug carries an alert indicative of vascular Occlusive and of heart failure as well. However, Iclusig has been the second-in-line treatment and has found great advocacy amongst physicians and patient advocacy groups, as the drug was found to have shown remission in patients who had otherwise become resistant to other drugs
In fact, ARIAD Pharmaceuticals, Inc. (NASDAQ:ARIA) had worked upon other channels available, such as the Investigational New Drug or IND channels to ensure that patients could be delivered Iclusing. Under the IND channel, the FDA allows the investigation of new drugs on single patients. FDA will however, exercise maximum control, by reviewing on a per-patient basis. Under this channel over 90patients could access this drug. Priced at $115,000 for an year, Iclusig definitely lives up to be one of the most expensive drugs currently available for the treatment of this condition. Now, with the drug being commercially available, patients have new hope!