FDA grants an ex­pand­ed Ay­vak­it la­bel to Blue­print Med­i­cines

The FDA on Mon­day ap­proved Blue­print Med­i­cines’ Ay­vak­it for a much broad­er, though still rare pop­u­la­tion of pa­tients with in­do­lent sys­temic mas­to­cy­to­sis, a dis­ease in which too many mast cells — a type of white blood cell — build up in the body.

The drug is the first ap­proved treat­ment for the con­di­tion, and the FDA grant­ed Blue­print a broad­er la­bel — it’s now ap­proved for all pa­tients with in­do­lent SM — than the clin­i­cal tri­als, which on­ly in­clud­ed pa­tients with mod­er­ate-to-se­vere symp­toms. The drug was ap­proved based on da­ta show­ing that it de­creased symp­toms of the dis­ease sig­nif­i­cant­ly more than place­bo over 24 weeks.

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