Iver­ic, Astel­las eye US la­bel ex­pan­sion for ge­o­graph­ic at­ro­phy drug af­ter pos­i­tive two-year da­ta

Iver­ic Bio and Astel­las Phar­ma’s Iz­er­vay has shown longer-term ef­fi­ca­cy promise in ge­o­graph­ic at­ro­phy (GA), paving the way for a US la­bel ex­pan­sion aimed at length­i­er treat­ment and thus in a stronger mar­ket po­si­tion against Apel­lis Phar­ma­ceu­ti­cals’ Syfovre.

Iver­ic’s com­ple­ment C5 in­hibitor Iz­er­vay won FDA ap­proval on Aug. 4 for GA sec­ondary to age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD), but the la­bel capped its use at up to 12 months. The de­ci­sion was based on da­ta from the GATH­ER1 and GATH­ER2 stud­ies, in­clud­ing on the rate of GA growth at six months and a year.

Endpoints News

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.