Bayer has secured another approval for its eye drug Eylea, partnered with Regeneron Pharmaceuticals, this time in Australia.
The German firm says that the Australian Therapeutic Goods Administration has given the thumbs-up to Eylea (aflibercept), an injection for the treatment of patients with wet age-related macular degeneration. Bayer plans to launch the drug, also known as VEGF Trap-Eye in Australia in the second half 2012.
The approval is based on two Phase III studies (VIEW 1 and VIEW 2) which demonstrated that Eylea dosed every other month, following three initial monthly injections, was non-inferior to the standard of care, Roche's Lucentis (ranibizumab) dosed every four weeks. Regeneron secured the green light for the drug in the USA in November.
The latest approval is great news for patients suffering from wet AMD in Australia, says Kemal Malik, head of global development at Bayer HealthCare, noting that the label on Eylea "allows for less frequent office visits and fewer injections with predictable pharmacology" compared to Lucentis.
Bayer has submitted applications for marketing authorisation in Europe, Japan, and other countries for Eylea for the treatment of wet AMD in 2011. The drug is also in Phase III studies for treatment of central retinal vein occlusion (CRVO), diabetic macular oedema and myopic choroidal neovascularisation, while Regeneron has filed it for CRVO in the USA; the injection has been granted a Prescription Drug User Fee Act (PDUFA) date of September 23.
Regeneron has raised its 2012 US sales forecast for Eylea to $250-$300 million from a previous forecast of $140-$160 million, while last month Bayer chief executive Marijn Dekkers said the drug will be a blockbuster.