Yesterday Savient shares dropped 38% after the company announced that the FDA's complete response letter said the agency would not approve the Company's Biologics License Application (BLA), citing deficiencies with the chemistry, manufacturing, and controls (CMC) section of the BLA. The FDA also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS) (Medication Guide and Communication Plan).
The Company intends to immediately request a meeting with the FDA to discuss and clarify the issues raised in the complete response letter.
One of those issues is that, since Savient has changed the process for making Krystexxa, FDA concluded that comparability data was not adequate to demonstrate drug produced by the new process is equivalent to the material used to establish the safety and efficacy of Krystexxa in Phase 3 clinical trials.
Savient plans to go back to old process for making Krystexxa
Savient can either go back to and validate the old process or conduct additional comparability clinical trials. A statement issued by the company says it expects to revert to and revalidate the old manufacturing process.
The FDA also wants:
- a Medication Guide for patients
- a Communication Plan directed to doctors likely to prescribe KRYSTEXXA with warnings about the risks of severe infusion reactions and possible anaphylaxis, if Krystexxa is given to patients with glucose-6-phopshate dehydrogenase (G6PD) deficiency and major cardiovascular events, and
- an Assessment Plan to monitor and assess the effectiveness of the Medication Guide and Communication Plan.
"While our timeline for resubmission to the FDA is subject to a number of uncertainties, we currently believe that we can target completion of our resubmission for early 2010. We hope to have more clarity on the expected timeline after we meet with the FDA to discuss the complete response letter," said Paul Hamelin, President of Savient Pharmaceuticals, in a statement.