1. Jun 26, 2020

FDA rejects Abicipar pegol for treatment of wet AMD

The U.S. Drug and Food Administration has rejected a new drug application for Abicipar pegol, a neovascular (wet) age-related macular degeneration (AMD). drug candidate, according to Allergan and co-developer Molecular Partners

According to a complete response letter to the biologics license application (BLA) for Abicipar pegol issued by the FDA, there was an unfavorable benefit-risk ratio in the treatment of wet AMD following administration of Abicipar pegol 2mg/0.05 mL

"We continue to believe in the need for treatment options that provide patients with reliable vision gains and less frequent dosing for the treatment of nAMD," said Michael R. Robinson, MD, Vice President, Global Therapeutic Area Head, Ophthalmology, AbbVie, in the release. "We are committed to working with the FDA to determine the appropriate next steps for Abicipar pegol."

Read the full press release here.