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.

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