Archive for the ‘PDUFA Dates’ Category.

KRYSTEXXA – PDUFA Date

September 14, 2010 is the PDUFA Date that’s been set for Savient’s KRYSTEXXA (pegloticase) which has been submitted for the treatment of gout.  The BLA was resubmitted earlier this year after receiving a Complete Response Letter last summer which highlighted a number of manufacturing deficiencies.  The company met with the FDA and agreed on a way forward that resulted in the resubmission which addressed the manufacturing issues but also included a safety update from their clinical trial data base.  The company recently announced that it had submitted the final stability update on July 28, 2010.

It all looks good on paper.  There’s lots of articles out there providing the safety and efficacy data from a lot of the clinical trials.  The company has met with the FDA and provided a resubmission of the requested manufacturing information.  So, why doesn’t it feel good to us?  We don’t really know for sure but with all of the problems that we’ve seen with recalls for manufacturing related issues and the growing list of products that are in short supply because of these problems, it just follows that the FDA chemistry reviewers and the inspectors just might be spending their time elsewhere.  It is a close call but we wouldn’t be surprised to see a 3 month delay on this PDUFA Date to allow the FDA some breathing room.

ACTHAR

By September 11, 2010, the FDA must decide on the approvability of ACTHAR (corticotropin gel) for the treatment of certain types of infantile spasms.  Following a very positive May 11, 2010 Advisory Committee recommendation, the FDA imposed a 3 month delay on the original PDUFA Date of June 11, 2010 to allow them to work on labeling issues and refine a REMS program for the drug with the sponsor, Questcor.  It seems reasonable to believe that the FDA action will be positive, considering the experience the company has with this drug.