First the blood thinner Xarelto was approved by the EMA, and within the same week Bayer has won the backing of the European Medicines Agency for another of its drugs, Eylea.
The drug was developed in collaboration with US company Regeneron, and has now been approved for the treatment of wet AMD, the most severe form of the eye disease Age-related Macular Degeneration.
Eylea has already been approved for the US market and is doing quite well there. Within 9 short months it has won a 13 % market share and expectations for 2012 sales have been raised to the region of 700 to 750 million dollars.
With the EMA-approval begins the battle for the European market, where Bayer – just as in the US – will face competition from Lucentis from Novartis and the cancer drug Avastin from Roche/Genentech, which is used off-label to treat the disease.
But Bayer seems to have an ace up its sleeve, as the new injection treatment will only have patients visiting the eye-clinic every other month, as opposed to the monthly treatment sessions seen in connection with existing treatments.
“We are pleased to see that new drugs for treating AMD are still being developed. It is a chronic condition, which is very costly to treat, although it is money well spent. We owe it to patients to improve treatment results even more than at present. So we welcome the development of new drugs, giving us even more opportunities for treating AMD,” Professor at the ophthalmologic department Glostrup Hospital and University of Copenhagen, Michael Larsen, says in a press release.
EMA’s approval of Eylea is based on results from two phase III studies (VIEW 1 and VIEW 2) of more than 2400 patients suffering from wet AMD.
Results during the first year showed that treatment with Eylea every second month, following an initial period of three monthly doses, had the same effect and safety profile as monthly treatments with Lucentis.
- translated by Martin Havtorn Petersen