Pe­di­atric la­bels: FDA ex­pands can­cer and dwarfism drugs from Genen­tech and Bio­Marin

Even younger pe­di­atric pa­tients with sol­id tu­mors or short-limbed dwarfism will now have ac­cess to treat­ment af­ter the FDA ap­proved la­bel ex­pan­sions late Fri­day for drugs by Genen­tech and Bio­Marin.

Cal­i­for­nia-based Bio­Marin said that the FDA had ap­proved a sup­ple­men­tal NDA for its drug Vox­zo­go, ex­pand­ing the drug to chil­dren of all ages. It had pre­vi­ous­ly been ap­proved for chil­dren 5 years and old­er. The drug is de­signed to in­crease lin­ear growth in pa­tients with achon­dropla­sia (the most com­mon type of short-limbed dwarfism) with open growth plates. It’s the on­ly ap­proved drug for the con­di­tion in chil­dren.

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