Citing an unfavorable benefit-risk ratio, the FDA rejected Allergan and co-developer Molecular Partners’ wet AMD drug candidate Abicipar pegol.
The FDA issued a complete response letter to the biologics license application (BLA) for Abicipar pegol, a novel, investigational DARPin therapy for patients with wet AMD.
“The rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05 mL results in an unfavorable benefit-risk ratio in the treatment of neovascular (wet) age-related macular degeneration (AMD),” according to the FDA.
AbbVie, which finalized its $63 billion acquisition of Allergan in May, said it plans to meet with the FDA to discuss their comments and determine next steps.
“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,” Michael R. Robinson, MD, Vice President, Global Therapeutic Area Head, Ophthalmology, AbbVie, said in a company news release. “We are committed to working with the FDA to determine the appropriate next steps for Abicipar pegol.”
In May, a pair of phase 3 studies (CEDAR and SEQUOIA) indicated that abicipar pegol was noninferior to ranibizumab (Lucentis) for achieving stable vision in people with wet AMD. Abicipar demonstrated similar efficacy after six or eight injections, compared with 13 Lucentis injections in the first year. However, the trials also showed it has more side effects than ranibizumab. Medication-related adverse events were more frequent in the abicipar groups (16.8% in the abicipar 2 mg every 8 weeks groups; and 20.4% in the abicipar 2 mg every 12 weeks group) than in the ranibizumab group (4.5% in the 0.5 mg every 4 weeks) because of the occurrence of intraocular inflammation.