dm+d

Unassigned

New Medicines

Information

Rayoqta
New molecular entity
Molecular Partners
Molecular Partners

Development and Regulatory status

Discontinued
Discontinued
Not approved
Aug 21AbbVie has pulled out of the licensing and collaboration deal for abicipar pegol, giving full worldwide development and sales right back to Molecular Partners who are considering their next steps. Molecular partners remain confident of abicipar's potential to offer patients with nAMD and DME a differentiated treatment option over existing therapies. They have made improvements for the manufacturing and formulation which overcome the inflammatory side effects that caused concerns for the FDA [12].
Jul 20The company are no longer pursuing a marketing authorisation application from the EMA for this indication at this time [11].
Jul 20Filing withdrawn by company. At the time of withdrawal, the Agency had concerns around efficacy and safety; the company has withdrawn the application because these could not be resolved within the available time frame. At the time of the withdrawal, the Agency’s opinion was that the benefits of the medicine did not outweigh its risks [10].
Jun 20US FDA issues Complete Response Letter rejecting Allergan’s BLA for abicipar pegol for neovascular AMD. Rejection is based on unfavourable risk-benefit ratio relating to rate of intraocular inflammation observed following administration [9].
Sep 19Filed in US [7]
Jun 19Filed in EU via centralised procedure [6].
Sep 18Launch planned for 2020 [5].
Nov 17PIII in EU. Will be filed via centralised procedure in EU [2].

Category

Vascular endothelial growth factor A (VEGF-A) inhibitor, based on proprietary Designed Ankyrin Repeat Protein (DARPin®) technology
In the UK, prevalence of wet AMD is estimated to be 1.2% (2.5% in those aged 65 or above and 6.3% in those aged 80 or above). Estimates indicate there may be approximately 26,000 people with wet AMD eligible for treatment in the UK each year. Wet AMD accounts for 10% of all AMD cases, but about 60% of those are considered advanced at presentation [8].
Age-related macular degeneration (AMD) - neovascular (wet)
Intravitreal

Further information

Yes

Trial or other data

Jul 18PIII trials (SEQUOIA and CEDAR) of abicipar pegol for neovascular AMD show 8 and 12-week regimens met pre-specified primary endpoint of non-inferiority to ranibizumab,. Studies in treatment-naïve patients measured proportion of treated patients with stable vision at week 52 and showed similar efficacy after 6 or 8 injections, vs 13 ranibizumab injections in first year of study. Regulatory filing with FDA is planned for first half of 2019 [4].
Jun 15PIII CEDAR trial evaluating safety and efficacy of abicipar pegol with ranibizumab in patients with wet AMD, starts (NCT02462928). 900 patients will be enrolled in the US, Czech Republic, Austria, Latvia and Spain, Argentina, Chile, Colombia, France, Germany, Hong Kong, Israel, South Korea, New Zealand, Philippines, Portugal, Singapore, and Switzerland. Collection of primary outcome data (Percentage of Patients with Best Corrected Visual Acuity (BCVA) Change from Baseline ≤15 Letters in the Study Eye) is expected to complete May 19 [3].
Jun 15PIII study to assess safety and efficacy of abicipar pegol in patients with wet AMD starts (SEQUOIA; NCT02462486). Abicipar pegol 2mg dosed every 8 and 12 weeks will be compared with ranibizumab dosed every 4 weeks, with patients receiving three loading doses of the drug. 900 patients will be enrolled in US, Hungary, Netherlands, Italy and Poland, Australia, Brazil, Canada, Denmark, Peru, Russia, South Africa, Taiwan, Turkey and the UK [3].

Evidence based evaluations