New Bayer, Regeneron eye drug gets EU agency backing
LONDON (Reuters) - EU drugs regulators have recommended Regeneron's and Bayer's eye drug Eylea for approval in a move likely to see the new medicine eat away further at rival Roche's market share.
Eylea treats wet age-related macular degeneration (AMD) -- the leading cause of blindness in the elderly.
Like its Roche rival Lucentis, it has been shown to restore some lost vision, but also offers the advantage of roughly half as many injections in the eye, as well as a lower cost.
The European Medicines Agency (EMA) said on Friday its expert committee considered the benefits of Eylea were its ability to preserve visual acuity, demonstrated over two years of treatment, by interfering with the progression of AMD.
It noted the most common side effects are conjunctival hemorrhage and eye pain, and said a drug monitoring plan would be implemented as part of the marketing authorization.
Recommendations for drug approvals by the EMA are normally endorsed by the European Commission within a couple of months.
In July, Regeneron significantly boosted its 2012 sales forecast for Eylea for the third time this year - raising its predictions to $750 million.
The U.S. biotech said second-quarter sales of the Eylea, which since its November approval has been gaining market share from Roche's Lucentis, were $194 million, up 57 percent from the previous quarter.
Regeneron has full marketing rights to Eylea in the United States and has a deal to share profits in Europe and other markets equally with Bayer.
Novartis sells Lucentis outside the United States.
(Reporting by Kate Kelland, editing by Chris Wickham)
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