News brief­ing: FDA ap­proves oint­ment for pre­can­cer skin le­sions; Take­da nabs pri­or­i­ty re­view for Shire drug

The FDA has cleared a new top­i­cal drug for ac­tinic ker­ato­sis, a kind of pre­can­cer le­sion that forms on skin due to chron­ic ex­po­sure to ul­tra­vi­o­let rays.

Klisyri is the first com­mer­cial prod­uct out of Buf­fa­lo, NY-based Athenex. The biotech is man­u­fac­tur­ing the drug, but it li­censed US and Eu­ro­pean rights Almi­rall, which ex­pects to launch in the US in the first quar­ter of 2021.

De­signed to in­hib­it mi­cro­tubule, Klisyri is an oint­ment that can be ap­plied to the face or scalp. In Phase III stud­ies in­volv­ing 702 pa­tients, 44% and 54% of those treat­ed with the drug (then dubbed tir­ban­ibu­lin) achieved com­plete clear­ance of le­sions on day 57, com­pared to 5% and 13% in the place­bo group.

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