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Regeneron Gets FDA Nod for Eylea Injection Prefilled Syringe

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Regeneron Pharmaceuticals, Inc. REGN announced that the FDA has approved the Chemistry, Manufacturing and Controls (CMC) Prior-Approval Supplement (PAS) for lead drug Eylea (aflibercept) Injection prefilled syringe.

The 2 mg, single-dose, sterilized prefilled syringe will provide physicians a new and a better way to administer Eylea that requires fewer preparation steps compared to vials.

The syringe will be available in the market later this year.

Eylea is the only anti-vascular endothelial growth factor (VEGF) approved to treat four retinal conditions with a single-dose strength prefilled syringe.


We remind investors that the drug is indicated to treat neovascular (wet) age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).

Last week, Regeneron reported better-than-expected results for the second quarter of 2019, wherein both earnings and sales beat estimates on strong Eylea sales.

Eylea sales in the United States came in at $1.160 billion, up 16.9% year over year.

Regeneron co-developed Eylea with the HealthCare unit of Bayer AG BAYRY. The company is solely responsible for the sales of this eye drug and entitled to profits in the United States. However, it shares profits and losses from the ex-U.S. Eylea sales equally with Bayer, except in Japan where it receives a royalty on net sales.

Meanwhile, sales of Dupixent has been strong as well since approval. Regeneron has a collaboration agreement with Sanofi SNY for this drug. The drug is approved for treating adults with moderate-to-severe atopic dermatitis. Regeneron is also working to expand Dupixent’s label to reduce dependence on Eylea. In May 2019, the European Commission (EC) approved the drug for use in adults and adolescents aged 12 years or older as an add-on maintenance treatment for severe asthma. The EC also approved the drug for use in adolescents aged 12-17 years with moderate-to-severe atopic dermatitis, who are candidates for systemic therapy. In June 2019, the FDA approved the drug for use with other medicines to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adults, whose disease is not controlled. Meanwhile, a phase III trial on the drug to treat severe atopic dermatitis in children aged 6-11 years met its primary and secondary endpoints.

We are impressed by Regeneron’s efforts to develop its pipeline. Earlier, the company inked a collaboration agreement with Alnylam Pharmaceuticals, Inc. ALNY to discover, develop and commercialize new RNA interference (RNAi) therapeutics for diseases of the eye and the central nervous system.

The successful development and commercialization of other candidates bode well for Regeneron and reduce its dependence on Eylea.

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