Application for FDA approval of KRN23/burosumab filed

The application for approval of KRN23/burosumab has been filed with the U.S. Food and Drug Administration, according to a press release by Ultragenyx Pharmaceutical and Kyowa Hakko Kirin.

The filing sets a number of timeframes in motion. The first one is a sixty-day review period that's just to confirm that the application meets certain technical requirements, rather than a substantive review of whether the treatment is safe and effective. At the end of that time period, the FDA will set other deadlines for action. You can read the full press release here: http://ir.ultragenyx.com/releasedetail.cfm?ReleaseID=1038129

The Network will be following the process closely and sharing what we learn with our community. We'll also be sharing some news about how your voice can be heard during the review process, as soon as we have the details worked out.

Stay tuned for updates, because things may start moving fast now! The new treatment has already been given breakthrough treatment designation for pediatric treatment, which should mean shorter turnaround for the FDA's review process. If you're not already following us on social media, make sure to do it now, so you'll get the latest news right away. 

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We'll also be talking more about the FDA process at the forum over the next months. You can find the thread here (where you'll need to log in first, or register if you haven't already): http://vps.xlhnetwork.org/~xlhforum/forum/index.php?topic=320.0