Posts Tagged Krystexxa

It was starting to look like 2009 was the year going banner year for new gout drugs.  That all came to a holt on Sunday as the FDA rejected the application for Savient Pharmaceuticals, Inc.’s drug, Krystexxa® (also called puricase or pegloticase).  This new drug used an enzyme not found in humans that breaks down uric acid in the body.  To prevent the body rejecting the foreign enzyme it is “locked up” in a molecular “cage”.  This cage allowed uric acid to flow in but blocks the immune system from attacking the enzyme (see, New Gout Drugs – Coming to a Pharmacy Near You).

Interestingly, the FDA did not have any complaints about the drug itself and found that the drug was safe and effective.  In fact, the FDA’s advisory board voted 14 to 1 to approve the drug.  However, the FDA raised concerns that the drug that was studied was created using a different manufacturing process than the drug that would be released to the public.  Due to concerns that this different manufacturing process could change the safety or effectiveness of the drug, the FDA rejected the drug until the manufacturer proves that the different manufacturing method resulted in a drug that was also safe and effective.
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