Regeneron’s Eylea neovascular age-related macular degeneration (AMD) injectable is well-positioned to lead the global wet AMD market as the fourth quarter of 2013 found the company dominating half of the branded anti-vascular endothelial growth factor (VEGF) market and half of the total wet AMD market, the New York-based drugmaker said in an investor call Tuesday.
Eylea (intravitreal aflibercept) also has between 40 and 50 percent of the wet AMD market in Germany, Australia and Japan, with launches through Bayer Healthcare in other EU, Latin American and Asian countries coming this year.
The drug has a supplemental application with an August 18 PDUFA date that may just add a diabetic macular edema indication, with a fourth indication for macular edema following branch retinal vein occlusion coming shortly after, the company said.
Three more products are in Regeneron’s pipeline as well:
Alirocumab, a PCSK9 antibody in Phase III trial for lowering LDL cholesterol — Regeneron expects to submit applications for U.S. and EU approval next year;
Sarilumab, an IL6 receptor antibody in Phase III for rheumatoid arthritis and Phase II for non-infectious Uveitis; and
Dupilumab, an IL-4 receptor alpha antibody which blocks both the IL-4 and IL-13 pathways and is in clinical development for asthma atopic dermatitis and nasal polyposis.
With all of these in mind, Regeneron is on track for five regulatory submissions and/or approvals over the next five years, executives said. — Lena Freund
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