Ahead of FDA de­ci­sion, Blue­print puts out full da­ta for ex­pand­ed Ay­vak­it la­bel

Blue­print Med­i­cines pre­sent­ed the full dataset for its drug Ay­vak­it at a med­ical con­fer­ence over the week­end as it heads to­wards an FDA de­ci­sion in May. Blue­print is hop­ing to ex­pand Ay­vak­it’s la­bel in­to a less ad­vanced form of sys­temic mas­to­cy­to­sis, a rare dis­ease in which too many mast cells, a type of white blood cell, build up in the body.

The drug was ap­proved for the ad­vanced form of the dis­ease in 2021. Blue­print re­port­ed topline da­ta for the Phase III PI­O­NEER tri­al in Au­gust, but left a key dat­a­point in the air.

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