FDA hits a green light on 2 more rare dis­ease drugs, giv­ing Alex­ion an ear­ly shot at pro­tect­ing PNH fran­chise

Faced with the prospect of a par­tial gov­ern­ment shut­down lat­er to­day, the FDA has pulled the trig­ger on a pair of new drug ap­provals.

Alex­ion got its nod 2 months ear­ly for ALXN1210 for parox­ys­mal noc­tur­nal he­mo­glo­bin­uria, or PNH, which will now be sold as Ul­tomiris. And Stem­line Ther­a­peu­tics won an FDA ap­proval to mar­ket El­zon­ris (tagrax­o­fusp-erzs) for rare cas­es of blas­tic plas­ma­cy­toid den­drit­ic cell neo­plasm, or BPD­CN.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER