NOV 6 CTGTAC

Results Wire: US FDA Advisory Committee: Does Not Support Novartis’ Farydak for Multiple Myeloma, But Does Support Rockwell Medical’s Triferic to Maintain Hemoglobin Levels in Patients with Kidney Disease– NOV 6, 2014 (ODAC)

On Thursday, November 6, 2014, in the morning session of the Oncologic Drugs Advisory Committee (ODAC), the committee did not support, by a vote of 2-Yes to 5-No, the safety and efficacy of Farydak (panobinostat) capsules, submitted by Novartis Pharmaceuticals Corporation. The proposed indication for this product is in combination with bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.

In the afternoon session, the committee supported, by a vote of 8-Yes to 3-No, the safety and efficacy of Triferic (ferric pyrophosphate) solution, for administration via hemodialysis dialysate, submitted by Rockwell Medical, Inc. The committee supported only part of the proposed indication; they voted in favor of the treatment of iron loss or iron deficiency to maintain hemoglobin (Hgb) in adult patients with hemodialysis-dependent stage 5 chronic kidney disease. The Committee believed that further study is needed to approve the drug for use in reducing the prescribed dose of erythropoiesis stimulating agent (ESA) required to maintain desired hemoglobin levels.

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