FDA rejects Allergan’s Abicipar pegol for neovascular age-related macular degeneration over benefit/risk concerns

pharmafile | June 29, 2020 | News story | Sales and Marketing AbbVie, Allergan, FDA, pharma 

The FDA has moved to reject Allergan’s vascular endothelial growth factor (VEGF) factor A inhibitor, Abicipar pegol, as treatment for the eye condition known as neovascular age-related macular degeneration (nAMD).

The drug application was supported by data from two trials which showed the non-inferiority of Abicipar pegol to Genentech’s Lucentis (ranibizumab) in treatment-naïve (nAMD), with six or eight injections of the former proving as effective as 13 doses of the latter after 52 weeks.

The rate of adverse events was also comparable across three treatment arms presented in the study, but upon reviewing supplied data, the US regulator ruled that the “rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.06 mL results in an unfavourable benefit-risk ratio.” Further specifics of the rejection were not given.

AbbVie completed its $63 billion acquisition of Allergan in May this year, and now says it plans to meet with FDA representatives to discuss the regulators decision and the path forward.

“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,” explained Michael R Robinson, Vice President, Global Therapeutic Area Head, Ophthalmology at AbbVie. “We are committed to working with the FDA to determine the appropriate next steps for Abicipar pegol.”

Matt Fellows

Related Content

Regeneron and Sanofi’s sBLA for Dupixent accepted by FDA for priority review

Regeneron Pharmaceuticals and Sanofi have announced that the US Food and Drug Administration (FDA) has …

FDA approves Eli Lilly and Boehringer Ingelheim’s Jardiance for chronic kidney disease treatment

Eli Lilly and Boehringer Ingelheim have announced that the US Food and Drug Administration (FDA) …

FDA grants ODD to Nexcella’s NXC-201 as treatment for amyloid light chain amyloidosis

Nexcella has announced that the US Food and Drug Administration (FDA) has granted orphan drug …

Latest content