EMA en­dors­es Teva's mi­graine drug; Dis­as­ter prone CTI Bio­Phar­ma re­scinds EU ap­pli­ca­tion for pa­cri­tinib

→ The EMA was busy on Fri­day. The Eu­ro­pean drug reg­u­la­tor, which is cur­rent­ly in the process of shift­ing its head­quar­ters to Am­s­ter­dam from Lon­don, rec­om­mend­ed the ap­proval of Te­va’s mi­graine-pre­ven­tion drug, Ajovy. A fi­nal de­ci­sion is ex­pect­ed in the first half of this year, and if ap­proved the treat­ment drug will be the first and on­ly an­ti-CGRP med­i­cine in the EU with both quar­ter­ly and month­ly dos­ing op­tions, the Is­raeli drug­mak­er said. CTI Bio­Phar­ma, how­ev­er, had bad news to re­port on the Eu­ro­pean front for its myelofi­bro­sis drug pa­cri­tinib. The no­to­ri­ous­ly fail­ure-prone drug de­vel­op­er an­nounced it was with­draw­ing an ap­pli­ca­tion to mar­ket the drug in the EU, fol­low­ing dis­cus­sions with the EMA. Last year, Shire backed away from a part­ner­ship with the ill-fat­ed com­pa­ny, fol­low­ing a mixed da­ta read­out from a piv­otal study that was pre­vi­ous­ly put on a full clin­i­cal hold — un­der the be­hest of the FDA — af­ter the death of sev­er­al pa­tients. The com­pa­ny’s shares $CTIC tum­bled more than 15% in ear­ly Fri­day trad­ing.

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