What happened? Anyone?
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Savient Pharmaceuticals, Inc. (the "Registrant") issued on December 7, 2011 a Dear Healthcare Provider Letter containing new guidance regarding the concurrent use of oral urate-lowering therapies and KRYSTEXXA(R) (pegloticase). In this letter, the Registrant recommends that oral urate-lowering medications be discontinued before a patient begins treatment with KRYSTEXXA, and that therapy with oral urate-lowering agents should not be instituted while the patient is taking KRYSTEXXA. It is important to note that during KYSTEXXA's clinical studies, patients discontinued oral urate-lowering therapy before commencing treatment with KRSYTEXXA. While it is difficult to draw finite conclusions from post-marketing adverse events reporting rates, to date, the Registrant has not seen any unexpected rates of infusion reactions and/or anaphylaxis, which to date remain consistent with the labeling for KRYSTEXXA, and the Registrant continues to closely monitor these events.
This new recommendation relates to an important safety warning already contained in the approved labeling for KRYSTEXXA, which highlights the need to monitor the serum uric acid levels of patients being treated with KRSYTEXXA, as patients who lose therapeutic response, defined as a rise in serum uric acid above 6 mg/dL, are at a higher risk of infusion reaction and anaphylaxis. The monitoring recommendation and its inclusion in the KRYSTEXXA labeling was the result of a post-hoc analysis of data from the KRYSTEXXA Phase 3 clinical trials and an open-label extension study, which further characterized the signs and symptoms of infusion reactions and anaphylaxis and their management in the context of the KRYSTEXXA clinical studies.
The Registrant's review of recent routine post-marketing safety surveillance indicates that some physicians are concurrently prescribing and some patients are concurrently using KRYSTEXXA and oral urate-lowering therapies, primarily allopurinol and febuxostat. The Registrant believes that the concurrent use of these therapies could prevent the detection of patients who have lost therapeutic response to KRYSTEXXA by blunting the rise in serum uric acid and thus interfere with the recommended monitoring of serum uric acid levels in KRSYTEXXA patients. As a result, this concurrent use could mask the detection of those patients who are at a higher risk for developing infusion reactions and/or anaphylaxis and could result in such patients not being discontinued from KRSYTEXXA treatment when warranted.
To ensure that physicians are informed of the risks of concurrent use, the Registrant has notified the U.S. Food and Drug Administration and issued a Dear Healthcare Provider Letter to provide these new recommendations.
***
Savient Pharmaceuticals, Inc. (the "Registrant") issued on December 7, 2011 a Dear Healthcare Provider Letter containing new guidance regarding the concurrent use of oral urate-lowering therapies and KRYSTEXXA(R) (pegloticase). In this letter, the Registrant recommends that oral urate-lowering medications be discontinued before a patient begins treatment with KRYSTEXXA, and that therapy with oral urate-lowering agents should not be instituted while the patient is taking KRYSTEXXA. It is important to note that during KYSTEXXA's clinical studies, patients discontinued oral urate-lowering therapy before commencing treatment with KRSYTEXXA. While it is difficult to draw finite conclusions from post-marketing adverse events reporting rates, to date, the Registrant has not seen any unexpected rates of infusion reactions and/or anaphylaxis, which to date remain consistent with the labeling for KRYSTEXXA, and the Registrant continues to closely monitor these events.
This new recommendation relates to an important safety warning already contained in the approved labeling for KRYSTEXXA, which highlights the need to monitor the serum uric acid levels of patients being treated with KRSYTEXXA, as patients who lose therapeutic response, defined as a rise in serum uric acid above 6 mg/dL, are at a higher risk of infusion reaction and anaphylaxis. The monitoring recommendation and its inclusion in the KRYSTEXXA labeling was the result of a post-hoc analysis of data from the KRYSTEXXA Phase 3 clinical trials and an open-label extension study, which further characterized the signs and symptoms of infusion reactions and anaphylaxis and their management in the context of the KRYSTEXXA clinical studies.
The Registrant's review of recent routine post-marketing safety surveillance indicates that some physicians are concurrently prescribing and some patients are concurrently using KRYSTEXXA and oral urate-lowering therapies, primarily allopurinol and febuxostat. The Registrant believes that the concurrent use of these therapies could prevent the detection of patients who have lost therapeutic response to KRYSTEXXA by blunting the rise in serum uric acid and thus interfere with the recommended monitoring of serum uric acid levels in KRSYTEXXA patients. As a result, this concurrent use could mask the detection of those patients who are at a higher risk for developing infusion reactions and/or anaphylaxis and could result in such patients not being discontinued from KRSYTEXXA treatment when warranted.
To ensure that physicians are informed of the risks of concurrent use, the Registrant has notified the U.S. Food and Drug Administration and issued a Dear Healthcare Provider Letter to provide these new recommendations.