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BRIEF-Ultragenyx provides regulatory update on burosumab (KRN23)
June 23, 2017 / 12:33 PM / 2 months ago

BRIEF-Ultragenyx provides regulatory update on burosumab (KRN23)

June 23 (Reuters) - Ultragenyx Pharmaceutical Inc

* Ultragenyx provides regulatory update on burosumab (krn23)

* Ultragenyx pharmaceutical inc - based on agreement, submission of burosumab bla is planned for second half of 2017

* Says ‍fda agreed that bla can be submitted based on available clinical data​

* Ultragenyx pharmaceutical inc - reached agreement with fda at a pre-biologics license application meeting on clinical package to support burosumab

* Ultragenyx pharmaceutical inc - fda confirmed that data from pediatric phase 3 study (cl301) would not be required for bla filing

* Says ‍fda confirmed that both pediatric and adult indications would be included in review​

* Ultragenyx - fda agreed that 64 week data from study cl201 in 5-12 year olds and 24 week data from study cl205 in 1-4 year olds would be sufficient for review

* Ultragenyx pharmaceutical inc - fda agreed review would be based on totality of data from adult phase 3 study cl303 including fracture healing data

* Ultragenyx pharmaceutical - fda would also accept some bone biopsy data from 48 week open label bone quality phase 3 study in adults if available during review as supportive evidence Source text for Eikon: Further company coverage:

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