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Regeneron (REGN) Gets FDA Nod for Eylea Label Expansion

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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved the label expansion of its eye drug, Eylea (aflibercept) injection to treat all stages of diabetic retinopathy (“DR”).

Diabetic retinopathy is a diabetes related complication that can cause damage to the blood vessels in the retina and may lead to severe vision loss. Eylea can now reduce the risk of blindness in DR patients.

Please note that the drug is already marketed as a treatment for neovascular (wet) age-related macular degeneration (“AMD”), macular edema following retinal vein occlusion and diabetic macular edema. The drug is the leading medication for the approved indications and generated sales of more than a billion dollar in the first quarter of 2019. Following the recent label expansion, the drug is eligible to treat an estimated eight million patients with DR in the United States, which will likely boost sales further.

Regeneron’s stock has declined 18.3% in the year so far against the industry’s rise of 2.5%.

 

The label expansion for Eylea was approved on the basis of encouraging six-month and one-year data from the phase III PANORAMA study.

In the study, 58% of patients who were treated with Eylea achieved a two-step or greater improvement in Diabetic Retinopathy Severity Scale (“DRSS”) score from baseline at week 24 compared with 6% of patients receiving sham injection.

Results improved when the treatment was continued for a period of one year.  The study showed that 80% and 65% of patients receiving Eylea every 8 weeks and 16 weeks, respectively, achieved two-step or greater improvement in DRSS compared to 15% for sham injection arm.

However, last month, Novartis (NVS - Free Report) announced that the FDA granted priority review to the biologics license application (“BLA”) seeking approval for brolucizumab for treating wet AMD. The candidate, in October 2018, demonstrated non-inferiority to Eylea in phase III studies for long-lasting effects in patients. Moreover, it showed superior improvement in reductions in retinal thickness due to fluid accumulation versus Eylea. A potential approval of brolucizumab will pose serious competition to Eylea.

Zacks Rank & Stocks to Consider

Regeneron currently carries a Zacks Rank #5 (Strong Sell). A couple of better-ranked stocks in the biotech sector include Anika Therapeutics Inc. (ANIK - Free Report) and Axovant Sciences Ltd. (AXGT - Free Report) , both sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Anika’s earnings estimates have been revised 4.9% upward for 2019 and 9.9% for 2020 over the past 60 days. The stock has gained 14.1% so far this year.

Axovant’s loss estimates narrowed 3.5% for 2019 and 12.2% for 2020 over the past 60 days.

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