Two new drugs get pos­i­tive rec­om­men­da­tions from EMA com­mit­tee, while two oth­ers get thumbs-down

The Eu­ro­pean Med­i­cines Agency’s hu­man med­i­cines com­mit­tee (CHMP) vot­ed in fa­vor of two new med­i­cines and against two oth­ers this week, in­clud­ing a neg­a­tive opin­ion for Apel­lis’ ge­o­graph­ic at­ro­phy treat­ment that has been ap­proved in the US for al­most a year.

Apel­lis an­tic­i­pat­ed the bad rec­om­men­da­tion, an­nounc­ing last month that it would file an ap­peal and seek re-ex­am­i­na­tion. Its drug, Syfovre (pegc­eta­coplan), was ap­proved in the US last Feb­ru­ary for the treat­ment of ge­o­graph­ic at­ro­phy fol­low­ing age-re­lat­ed mac­u­lar de­gen­er­a­tion, a con­di­tion that can lead to ir­re­versible vi­sion loss. How­ev­er, its US launch was trou­bled by rare cas­es of an in­flam­ma­to­ry eye con­di­tion called reti­nal vas­culi­tis.

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