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news.Savient Pharmaceuticals has announced that some production batches of Krystexxa, its recently-approved second-line treatment for gout, have failed to meet quality standards.
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Following the batch failures, the company released a statement indicating the problems are within normal industry failure rates experienced for the commencement of biologic commercial manufacturing.
The offending batches of the drug were manufactured by the company’s third party contractor manufacturing organisations in Israel and Merck Biomanufacturing Network.
According to the company, with the assistance of an outside manufacturing and quality consulting firm, Savient personnel have conducted a review these batch failures and have identified the root cause of the batch failures at the company’s third party CMO in Israel and Merck.
Under the direction of the company, the company’s CMO in Israel and Merck are in the process of implementing remediation steps to minimise or eliminate these failures.
Krystexxa (pegloticase), which was approved in the US in September, is a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy
According to the company, the promotional launch of Krystexxa is expected in the first quarter of 2011.