Pegloticase Fails To Help Gout Patients
Posted by GoutPal in Gout Cures, tags: krystexxa, pegloticase, _savientAgainst a background of concerns about the safety of this new gout treatment, the FDA have turned down Savient’s application.
Resubmission is possible, but this is not feasible until 2010.
Pegloticase has been shown to be effective in lowering uric acid in clinical trials, and is aimed at those gout patients who cannot tolerate allopurinol. It uses a genetically engineered form of uricase to breakdown uric acid in the body. This enzyme is common in many animals, but not humans.
The failure of Krystexxa to gain FDA approval means that it will be unavailable to help gout patients for some time, though there may still be access through ongoing clinical trials.
Apparently, Savient have changed the manufacturing process for pegloticase. Resubmission will require either a return to the previous method, or rerunning the clinical trials with the output from the changed process. It is expected that Savient will revert to the original process.
Approval is also dependent on Savient providing:
- A Medication Guide for using Krystexxa safely and effectively.
- A Communication Plan for Savient to correctly notify healthcare providers about infusion risks, life threatening allergic reactions, and risks for patients who also have Glucose-6-phosphate dehydrogenase deficiency (G-6-PD), or heart problems.
- An Assessment Plan for ensuring that the other 2 plans ensure that the risks o Krystexxa are properly communicated to doctor and patient.
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