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Regeneron's sBLA for Eylea Accepted by FDA, Action Date Set

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Regeneron Pharmaceuticals, Inc. REGN announced that the FDA has accepted for review the company's supplemental Biologics License Application (sBLA) for the label expansion of Eylea Injection. The company is seeking approval a for a 12-week dosing interval of Eylea (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD) based on physician's assessment. The action date set by the FDA is Aug 11, 2018.

So far this year, shares of the company have rallied 3.9% compared with the industry’s gain of 3%.

We note that Eylea  (aflibercept) is approved in the United States, the EU, Japan and other countries for the treatment of neovascular age-related macular degeneration (wet AMD), diabetic macular edema (DME), macular edema following retinal vein occlusion, which includes macular edema following central retinal vein occlusion and macular edema following branch retinal vein occlusion.

Eylea injection is indicated for the treatment of patients with-neovascular (Wet) age-related macular degeneration (AMD). The recommended dose for Eylea is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months).

Eylea may be dosed once per month, but in most patients, additional benefit was not seen with this dosing plan. It is also approved for the treatment of macular edema following Retinal Vein Occlusion (RVO). The recommended dose for Eylea is 2 mg administered by intravitreal injection every 4 weeks (monthly).

It also treats people suffering from diabetic macular edema (DME) and diabetic retinopathy (DR) in patients with DME. The recommended dose is 2 mg administered by intravitreal injection every 4 weeks (monthly) for the first five injections, followed by 2 mg once every 8 weeks (2 months).

The sBLA submission is based on an integrated analysis of two-year results from — VIEW 1 and VIEW 2 — two phase III studies that investigated the treatment of Eylea in patients with wet AMD. The integrated studies found that 51% of patients in the study had their Eylea dosing interval extended to every 12 weeks at the beginning of the second year (week 52) of treatment.

The patients were able to maintain this every 12-week dosing interval and their best-corrected visual acuity (BCVA) gains when they were assessed at the end of the second year (week 96). The second year results confirmed the sustainability of the vision gains achieved by EYLEA with a less than monthly dosing frequency. Thus, if approved for this indication it will mean that the patients will have to take fewer injections of Eylea than before.

Label expansion into additional indications would give Eylea access to higher patient population and increase the commercial potential of the drug.

Meanwhile, Novartis NVS is developing brolucizumab for treating neovascular (wet) AMD. The candidate in November 2017, demonstrated non-inferiority to Eylea in phase III studies for long-lasting effects in patients. Moreover, it has shown superior improvement in reductions in retinal thickness due to fluid accumulation versus Eylea. A potential approval of brolucizumab will hurt Regeneron’s product sales.

Ophthotech Corp. OPHT is also developing its pipeline candidate, Zimura, in a phase IIa study for treating wet AMD with data expected late next year.

Regeneron Pharmaceuticals, Inc. Price

Regeneron Pharmaceuticals, Inc. Price | Regeneron Pharmaceuticals, Inc. Quote

Zacks Rank & Key Pick

Regeneron carries a Zacks Rank #3 (Hold). A better-ranked health care stock in the same space is Johnson & Johnson JNJ sporting a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Johnson and Johnson’s earnings per share estimates have moved up from $7.19 to $7.28 for 2017 and from $7.75 to $7.85 for 2018, over the last 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters, with an average beat of 3.12%. The share price of the company has increased 22.5% year to date.

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