3.238.111.130
dgid:
enl:
npi:0
-Advertisement-
-Advertisement-
Geographic Atrophy

FDA accepts NDA, grants priority review for avacincaptad pegol for geographic atrophy

Posted on

The U.S. Food and Drug Administration has accepted Iveric bio’s New Drug Application (NDA) for avacincaptad pegol (ACP), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD), according to a press release.

The NDA has been granted Priority Review with a Prescription Drug User Fee Act goal date of August 19, 2023. The company also announced that, at this time, the FDA has not identified any potential review issues and the FDA is not currently planning to hold an Advisory Committee meeting for ACP.

The NDA submission is based on the 12-month pre-specified primary efficacy and safety results from the GATHER1 and GATHER2 clinical trials, in which ACP achieve the pre-specified 12-month primary endpoint with observed efficacy rates of up to 35%.

“We believe our Special Protocol Assessment for GATHER2, rolling review, Breakthrough Therapy designation and now Priority Review underscore the strength of our GATHER1 and GATHER2 results,” said Pravin U. Dugel, President of Iveric Bio, in the press release. “We continue to accelerate our commercial launch plans and prepare for a potential approval of ACP for the treatment of GA throughout the AMD disease continuum. This is important because AMD leads to irreversible, and in many cases catastrophic, vision loss.”

Read the full press release here.

-Advertisement-
-Advertisement-
-Advertisement-
-Advertisement-
Click to access the login or register cheese
-Advertisement-
-Advertisement-