Shots:
- The EC has approved an expansion of the indication for Crysvita (burosumab) for the treatment of X-linked hypophosphataemia (XLH), to incl. infants from 1mos. to 1yr. of age
- Approval was supported by data from P-I/II (BUR-CL207) study assessing safety, tolerability, PK & efficacy of burosumab in pts with XLH from birth to 1yr. Trial showed that safety was consistent with the established safety profile
- Approval also grants Crysvita a two-year extension of orphan market exclusivity in the EU for XLH, extending regulatory protection from Feb 2028 to Feb 2030
Ref: Businesswire | Image: Kyowa Kirin | Press Release
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