Genentech’s food allergy medication gets priority review nod from the FDA

Genen­tech’s Xo­lair scored a pri­or­i­ty re­view from the FDA on Wednes­day for the re­duc­tion of al­ler­gic re­ac­tions in adult and pe­di­atric pa­tients 1 year and old­er, the com­pa­ny said, with the agency ex­pect­ed to make a de­ci­sion in the first quar­ter of 2024.

If it’s ap­proved, it would be the first med­i­cine to re­duce al­ler­gic re­ac­tions to mul­ti­ple foods, ac­cord­ing to the com­pa­ny. The FDA ac­cept­ed Genen­tech’s sBLA based on the first stage of the Phase III OUt­MATCH study. That study in­ves­ti­gat­ed Xo­lair, the brand name for oma­l­izum­ab, in pa­tients al­ler­gic to peanuts, milk, eggs and cashews. Pa­tients got ei­ther place­bo or Xo­lair in­jec­tions ei­ther every two or four weeks for 16 to 20 weeks.

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