Date: 2012-11-27
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) Regeneron Pharmaceuticals (USA - NY)
Disease: neovascular form of age-related macular degeneration (wet AMD)
Latest news: * On May 31, 2013, the National Institute for Health and Care Excellence (NICE) has announced that Eylea® (aflibercept solution for injection - VEGF Trap-Eye) should be recommended for the treatment of patients with wet age-related macular degeneration (wAMD). This decision means that eligible patients in England and Wales will have an alternative treatment available to them which has been shown in two clinical studies to work as well as current treatment, but requires fewer hospital visits, reducing the burden for patients, relatives and the NHS. The Scottish Medicines Consortium (SMC) accepted Eylea® for use within NHS Scotland for the treatment of wAMD on 8th April 2013.
* On November 27, 2012, Bayer HealthCare announced that Eylea® (aflibercept solution for injection), also known in the scientific literature as VEGF Trap-Eye, has been approved by the European Commission for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2 mg.
* On September 28, 2012, Bayer HealthCare has received approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan for Eylea® (aflibercept) Injection for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2 milligram (mg) intravitreal injection per month for three consecutive months (treatment initiation). Thereafter, in the maintenance phase, the recommended treatment is usually one intravitreal injection every two months. The dosing interval may be adjusted according to patient response.
The MHLW approval is based upon the results of two Phase 3clinical studies (VIEW 1 and VIEW 2), which demonstrated that Eylea® dosed every other month, following three initial monthly doses, was non-inferior to Lucentis® (ranibizumab injection) dosed every four weeks, as measured by the primary endpoint of the proportion of patients who maintained visual acuity (less than 15 letters of vision lost on an eye chart) over 52 weeks. The most common adverse reactions (frequency of 5.0% or more) reported in patients receiving EYLEA were conjunctival hemorrhage, eye pain, vitreous detachment, cataract, vitreous floaters, and increased intraocular pressure.
Beyond the wet AMD indication, Phase III trials are currently underway with VEGF Trap-Eye in the treatment of diabetic macular edema (DME) and myopic choroidal neovascularization (mCNV).
Eylea® was already approved in the United States in Macular Edema following Central Retinal Vein Occlusion (CRVO) and in wet AMD. Bayer plans to submit for marketing authorization in CRVO in Europe at the end of 2012.
* On September 20, 2012, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the authorisation of Eylea® for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD). The benefits with Eylea® are its ability to preserve visual acuity, demonstrated over two years of treatment, by interfering with the progression of the neovascular (wet) form of age-related macular degeneration. The most common side effects are conjunctival haemorrhage and eye pain. A pharmacovigilance plan for Eylea® will be implemented as part of the marketing authorisation.
* On March 8, 2012, Regeneron and Bayer have announced approval of Eylea® (aflibercept) injection for the treatment of wet age-related macular degeneration in Australia. Eylea® (aflibercept) Injection is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (wet AMD) at a recommended dose of 2 mg via intravitreal injection per month for three consecutive months, followed by 2 milligrams via intravitreal injection every two months. Bayer Healthcare plans to launch Eylea® in Australia in the second half 2012. The approval of Eylea® is based upon the results of two positive Phase 3 clinical studies (VIEW 1 and VIEW 2) which demonstrated that Eylea® dosed every other month, following 3 initial monthly injections, was non-inferior to Lucentis® (ranibizumab injection) dosed every four weeks, as measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks. The most common adverse reactions (frequency of 5% or more) reported in patients receiving Eylea®were conjunctival hemorrhage, cataract, eye pain, vitreous detachment, vitreous floaters, and increased intraocular pressure.
* On June 7, 2011, Bayer HealthCare and Regeneron Pharmaceuticals have announced that Bayer HealthCare has submitted an application for marketing authorization in Europe for VEGF Trap-Eye for the treatment of the neovascular form of age-related macular degeneration (wet AMD). Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye for the treatment of wet AMD, central retinal vein occlusion (CRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV).
The VEGF Trap-Eye submission is based on the positive results from two Phase III trials, the VIEW 1 study and the VIEW 2 study. In these trials, all regimens of VEGF Trap-Eye, including 2 mg VEGF Trap-Eye dosed every two months (following three loading doses), successfully met the primary endpoint of non-inferiority, compared to the current standard of care, ranibizumab 0.5 mg dosed every month. The primary endpoint analysis was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab at the dose that is currently known to provide the best possible efficacy. A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The ocular adverse events were balanced across all treatment groups in both studies. There were no notable differences in non-ocular adverse events between the study arms.
Patents:
Submission of marketing authorization application USA : 2011-02-01 (submitted by Regeneron Pharmaceuticals)
Submission of marketing authorization application UE: 2011-06-07 (submitted by Bayer Healthcare)
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2011-11-18
UE authorization: 2012-11-27
Favourable opinion UE: 2012-09-20
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
