Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has approved a supplemental Biologics License Application (sBLA) for its flagship ophthalmology drug, Eylea injection in patients with wet age-related macular degeneration (wet AMD).
The sBLA was based on second-year data from the phase III VIEW 1 and 2 trials, in which patients with wet AMD were treated with a modified 12-week dosing schedule (doses given at least every 12 weeks, and additional doses as needed).
The news comes as a surprise as earlier this month, the FDA issued a complete response letter (CRL) to its sBLA due to ongoing labeling discussions.
We note that Eylea is already approved in wet AMD for every four- or eight-week dosing intervals, after three initial monthly doses.
Regeneron has co-developed Eylea with the HealthCare unit of Bayer AG (BAYRY - Free Report) . Eylea is approved in the United States, EU, Japan and other countries for the treatment of 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. It is also approved in the EU, Japan and certain other countries outside the United States for the treatment of myopic choroidal neovascularization and in the United States for the treatment of diabetic retinopathy in patients with DME.
Regeneron recently submitted an sBLA for Eylea for the treatment of diabetic retinopathy. Eylea is Regeneron’s flagship drug and a potential label expansion will boost sales.
Regeneron’s stock has lost 0.3% in the year so far compared with the industry’s 6.1% decline.
Meanwhile, Novartis AG (NVS - Free Report) is also evaluating brolucizumab (RTH258) in neovascular age-related macular degeneration (nAMD). In April 2018, Novartis announced positive data from late-stage trials on the candidate. The data from the studies showed that patients identified for brolucizumab 12-week treatment interval in phase III HAWK and HARRIER trials had 87% and 83% probability of successfully continuing on a 12-week interval through week 48, respectively.
Regeneron is working to expand its portfolio/pipeline. Label expansion of approved drugs will further boost sales. The company and partner Sanofi (SNY - Free Report) are also working to expand Dupixent’s label. Dupixent is being studied in asthma, adolescent and pediatric atopic dermatitis, nasal polyps, eosinophilic esophagitis (EoE) and grass immunotherapy, with additional studies planned in 2018.
Regeneron currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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