Citing an unfavourable benefit to risk ratio, the US Federal Drug Administration (FDA) has rejected Allergan and co-developer Molecular Partners’ wet age-related macular degeneration (AMD) drug candidate Abicipar pegol.
“The rate of intraocular inflammation observed following administration of Abicipar pegol 2mg/0.05ml results in an unfavourable benefit-risk ratio in the treatment of neovascular (wet) AMD,” said the FDA in its response letter.
AbbVie, which finalised its US$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,” said AbbVie’s vice-president Dr Michael Robinson. “We are committed to working with the FDA to determine the appropriate next steps for Abicipar pegol.”
In May, phase III studies Cedar and Sequia indicated that Abicipar pegol was non-inferior to ranibizumab (Lucentis) 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 demonstrated it had more side effects. Medication-related adverse events were 16.8% in the Abicipar 2mg every eight weeks groups and 20.4% in the Abicipar 2mg every 12 weeks group, compared with 4.5% in the 0.5mg every four weeks ranibizumab group, due to the occurrence of intraocular inflammation.
