FDA OKs Hizen­tra for rare au­toim­mune dis­ease CIDP

Just one day af­ter get­ting cleared to sell its new rare dis­ease drug Hizen­tra in Eu­rope, Penn­syl­va­nia drug­mak­er CSL Behring got the green light from US reg­u­la­tors to mar­ket the drug in the states.

The med is a main­te­nance ther­a­py for a rare au­toim­mune dis­ease called chron­ic in­flam­ma­to­ry de­myeli­nat­ing polyneu­ropa­thy, or CIDP. The con­di­tion, al­so known as Vi­dau­r­ri’s dis­ease, is be­lieved to be caused by mis­guid­ed im­mune cells at­tack­ing the nerves of the body in­stead of pro­tect­ing the body from in­fec­tion. As a re­sult, the af­fect­ed nerves fail to re­spond, or re­spond on­ly weak­ly, and on oc­ca­sion, in­or­di­nate­ly, caus­ing numb­ing, tin­gling, pain, pro­gres­sive mus­cle weak­ness, loss of deep ten­don re­flex­es, fa­tigue, and ab­nor­mal sen­sa­tions. Pa­tients are gen­er­al­ly treat­ed with in­tra­venous im­munoglob­u­lin.

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