Thursday, November 10, 2016

Ultragenyx filing for regulatory approval of KRN23 in 2017

According to a new press release from Ultragenyx Pharmaceutical, there are plans to file for approval of KRN23 in the US in the second half of 2017. An application is expected to be filed even sooner (around the end of 2016) for Conditional Marketing authorization in Europe.

You can read the entire press release here:

Also of note in the press release is the following: "Data from the Phase 3 study in adult XLH patients expected in the first half of 2017. The fully-enrolled Phase 3 study will evaluate change in serum phosphorus levels, pain, stiffness, physical function, and safety of monthly KRN23 compared with placebo over 24 weeks in 134 adult XLH patients."

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.