Date: 2015-10-30
Type of information: Granting of a Market Authorisation in the EU
Product name: Eylea® (VEGF Trap-Eye)
Compound: aflibercept
Therapeutic area: Ophtalmological diseases
Action mechanism: fusion protein/VEGF receptor. Eylea® is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Eylea® acts as a soluble decoy receptor that binds VEGF-A and placental growth factor (PlGF) and thereby can inhibit the binding and activation of these cognate VEGF receptors.
Company: Bayer Healthcare (Germany)
Disease: myopic choroidal neovascularization (mCNV)
Latest news: * On October 30, 2015, Bayer has received approval from the European Commission for Eylea® (aflibercept solution for injection into the eye) in a fifth indication. Eylea® is now also approved for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV).Bayer plans for an immediate introduction to the market with Germany being one of the first launch countries in Europe. * On 24 September 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for Eylea®. The CHMP adopted a new indication as follows: treatment of visual impairment due to myopic choroidal neovascularisation (myopic CNV). The full indication for Eylea will be as follows: “Eylea® is indicated for adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) * On March 11, 2015, Bayer HealthCare has submitted an application for marketing authorization of aflibercept solution for intravitreal injection for the treatment of myopic choroidal neovascularization (myopic CNV) to the European Medicines Agency (EMA). The application is based on positive data from the Phase 3 MYRROR study in myopic CNV. MYRROR was a multi-center, double-masked, sham-controlled trial that randomized 122 patients to receive either aflibercept solution 2 mg or sham. The trial was designed to assess the safety and efficacy of aflibercept solution, with three quarters of patients receiving an injection of aflibercept solution and one quarter receiving a sham injection. The primary endpoint of the study was the mean change at week 24 from baseline in best-corrected visual acuity (BCVA) as measured on the Early Treatment Diabetic Retinopathy Scale (ETDRS) eye chart. Patients in the active treatment arm received one initial 2 mg dose of aflibercept solution. Patients were evaluated every 4 weeks and were eligible to receive additional intravitreal injections if the myopic CNV persisted or recurred through week 44. Patients on the sham arm received monthly sham injections through week 20. Starting at week 24, they could receive a single injection of aflibercept solution 2 mg and were eligible to receive additional treatment in case of CNV persistence or recurrence through week 44. In the MYRROR study, patients receiving aflibercept solution had a mean improvement in best-corrected visual acuity (BCVA) at week 24 of 12.1 letters from baseline, compared to a loss of 2 letters in patients receiving sham injections (p<0.0001). The efficacy gains seen at week 24 were maintained and even extended further in the EYLEA arm until week 48. Patients received in the first quarter of the study, i.e. from baseline to week 12, a median of 2 injections. In each of the following three quarters, the median of injections was 0. Aflibercept solution for intravitreal injection has been approved already under the brand name Eylea® in Japan for the treatment of myopic CNV in September 2014. In addition, Eylea® has been approved in more than 80 countries for the treatment of patients with neovascular age-related macular degeneration (wet AMD), in around 30 countries for the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO) and over 40 countries for the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). Eylea® is also approved for the treatment of diabetic macular edema (DME) in more than 40 countries. Over three million doses of Eylea® have been administered since launch worldwide. For the treatment of macular edema secondary to branch retinal vein occlusion (BRVO), an application for marketing authorization has been submitted in Japan.
• visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO),
• visual impairment due to diabetic macular oedema (DME) ,
• visual impairment due to myopic choroidal neovascularisation (myopic CNV)
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2015-03-11
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization:
UE authorization: 2015-10-30
Favourable opinion UE: 2015-09-24
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
