Posts tagged ‘Astra Zeneca’

PDUFA Date dapagliflozin

Well, the FDA has ruled on the AZN / BMY drug dapagliflozin for the treatment of diabetes.  It comes as no surprise that they feel the benefits do not outweigh the risks.  As was pointed out here in July 2011, the unknowns about safety that were also raised by the Advisory Committee, make for a difficult approval.  The only good thing that can be said for this new class of drugs is that the FDA has set the bar for approval.  Those that follow AZN and BMY with NDA submissions are well advised to clear the bar.

ZICTIFA – Advisory Committee Meeting

On December 2, 2010, Astra Zeneca will present data to the FDA Oncology Advisory Committee for ZICTIFA (vandetanib) hoping to get their recommendation for the treatment of unrestable (non-operable) locally advanced or metastatic medullary thyroid cancer.

This should be an interesting discussion to watch – a study of contrasts.  While the disease is not one of the most serious cancers, the clinical trial data show a more than 50% increase in survival time BUT with a 31% incidence of serious adverse experiences compared to only 13% for placebo.  So, the balance of a significant improvement in survival will be compared with a significant incidence of serious adverse experiences will be discussed.  How does FDA feel about this?  They appear to be leaning towards approval of this drug but with some caveats.  They are asking the Committee to discuss 2 options that will help improve the benefit risk ratio.  The first is restricting the labeling to a more serious patient population than AZ is seeking.  The FDA is asking the Committee to limit use to patients with progressive, symptomatic medullary thyroid cancer.  The second option is for the Committee to discuss the evaluation of lower doses in a post-marketing study.

If AZN can provide the sub group analyses that show similar improvement in these more serious patients and also provide data showing a reduction in the incidence of the serious adverse events in patients who had their dose adjusted downward, the Committee might be just inclined to give their recommendation for approval in this limited population with more specific instructions on dosing.