New EU indication for Bayer and Regeneron eye drug
pharmafile | February 27, 2015 | News story | Sales and Marketing | Bayer, European Commission, Eylea, aflibercept
Bayer and Regeneron’s Eylea is now indicated for every type of the eye disease retinal vein occlusion (RVO) thanks to a new European Commission approval.
Previously Eylea (aflibercept) had only been approved for macular edema (swelling in the eye) following central retinal vein occlusion (CRVO), but this new approval now includes the far more common branch retinal vein occlusion (BRVO).
Dr Joerg Moeller who is the head of global development at Bayer, says: “RVO is a chronic disease that requires early and ongoing management to obtain the best possible vision, which is critical as many patients are still of working age. This new therapeutic approach allows physicians to individualise therapy for each patient, maximising time between treatments.”
Both types of RVO occur when different blood vessels in the eyes become blocked. This leads to the release of a growth factor that causes the swelling. It is estimated to affect around 16 million people worldwide – with BRVO making up 14 million of those cases – and can lead to loss of vision. Eylea is an injectable drug that works by inhibiting the growth of new blood vessels and preventing fluid escaping from them.
The drug is co-developed by Bayer and Regeneron. Regeneron has exclusive rights to it in the US while Bayer licensed the marketing rights for other regions – where the companies have equal share of any profits from the drug’s sales.
It is also currently approved for the treatment of wet age-related macular degeneration (wet AMD) and diabetic macular edema in Europe.
The new approval is based on data from the Phase III VIBRANT trial, which found that more than half of the patients with visual impairment due to BRVO regained at least some level of vision.
Eylea was one of the five new products that Bayer cited for driving growth in its pharmaceutical division during the firm’s 2014 financial results yesterday.
Along with anticoagulant Xarelto (rivaroxaban), cancer drugs Stivarga (regorafenib) and Xofigo (Radium-223 chloride), and Adempas (riociguat) for the treatment of pulmonary hypertension, Eylea contributed to year-on-year increase of 11.2% of sales of prescription pharmaceuticals.
George Underwood
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