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Regeneron (REGN) Gets FDA Nod for Higher Dose of Eylea
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Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has finally approved aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) under the brand name Eylea HD.
The recommended dose for the drug is 8 mg every 4 weeks for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in wAMD and DME and every 8 to 12 weeks (2 to 3 months) for DR.
The approval by the regulatory body was based on the 48-week results of two studies, PULSAR and PHOTON. These two double-masked, active-controlled pivotal trials compared Eylea HD to aflibercept injection at 2 mg.
We note that a 2 mg dose of aflibercept is already approved under the brand name Eylea for various ophthalmology indications.
Data from the above-mentioned studies showed Eylea HD demonstrated clinically equivalent vision gains to Eylea that were maintained with fewer injections.
We remind investors that the FDA earlier issued a complete response letter (CRL) to the company’s biologics license application seeking approval for the 8 mg dose strength of aflibercept for the treatment of patients with wAMD, DME and DR.
The cause of the CRL was only an ongoing review of inspection findings at a third-party filler and the FDA did not request any additional clinical data or studies.
The approval of Eylea HD will relieve investors somewhat, as Eylea sales have been under pressure in the last couple of quarters due to competition from Roche’s Vabysmo and sale deductions.
Regulatory filings for aflibercept 8 mg are under review in Europe and Japan. Submissions to other regulatory authorities in additional countries are also planned.
Please note that Regeneron co-developed Eylea with Bayer AG (BAYRY - Free Report) . Regeneron records net product sales of Eylea in the United States and Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Concurrently, the FDA approved pozelimab-bbfg for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. The candidate has been approved under the brand name Veopoz.
Per Regeneron, Veopoz is the first and only treatment indicated specifically for CHAPLE, an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms.
Veopoz is also being evaluated in combination with Alnylam’s (ALNY - Free Report) cemdisiran (siRNAi C5 inhibitor) as an investigational combination therapy for the treatment of other complement-mediated disorders, including paroxysmal nocturnal hemoglobinuria and myasthenia gravis.
In 2019, Regeneron and Alnylam entered into a global, strategic collaboration to discover, develop and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver. In the same year, both companies entered into a license agreement for a combination consisting of cemdisiran and pozelimab. Alnylam is entitled to receive royalties on sales of the combination (if any), as well as sales milestones.
Regeneron’s shares have gained 14.6% so far this year against the industry’s decline of 14.3%.
Image Source: Zacks Investment Research
REGN is looking to diversify its revenue base. Earlier in the month, the company reported better-than-expected second-quarter 2023 results, even though lead drug Eylea’s sales declined.
The performance came on the back of the asthma drug Dupixent, for which the company has a collaboration with Sanofi (SNY - Free Report) . Dupixent maintains its stellar performance, driven by continued strong demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
Image: Bigstock
Regeneron (REGN) Gets FDA Nod for Higher Dose of Eylea
Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the FDA has finally approved aflibercept 8 mg for the treatment of patients with wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) under the brand name Eylea HD.
The recommended dose for the drug is 8 mg every 4 weeks for the first 3 months across all indications, followed by 8 mg every 8 to 16 weeks (2 to 4 months) in wAMD and DME and every 8 to 12 weeks (2 to 3 months) for DR.
The approval by the regulatory body was based on the 48-week results of two studies, PULSAR and PHOTON. These two double-masked, active-controlled pivotal trials compared Eylea HD to aflibercept injection at 2 mg.
We note that a 2 mg dose of aflibercept is already approved under the brand name Eylea for various ophthalmology indications.
Data from the above-mentioned studies showed Eylea HD demonstrated clinically equivalent vision gains to Eylea that were maintained with fewer injections.
We remind investors that the FDA earlier issued a complete response letter (CRL) to the company’s biologics license application seeking approval for the 8 mg dose strength of aflibercept for the treatment of patients with wAMD, DME and DR.
The cause of the CRL was only an ongoing review of inspection findings at a third-party filler and the FDA did not request any additional clinical data or studies.
The approval of Eylea HD will relieve investors somewhat, as Eylea sales have been under pressure in the last couple of quarters due to competition from Roche’s Vabysmo and sale deductions.
Regulatory filings for aflibercept 8 mg are under review in Europe and Japan. Submissions to other regulatory authorities in additional countries are also planned.
Please note that Regeneron co-developed Eylea with Bayer AG (BAYRY - Free Report) . Regeneron records net product sales of Eylea in the United States and Bayer records net product sales of Eylea outside the United States. Regeneron records its share of profits/losses in connection with sales of Eylea outside the United States.
Concurrently, the FDA approved pozelimab-bbfg for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy. The candidate has been approved under the brand name Veopoz.
Per Regeneron, Veopoz is the first and only treatment indicated specifically for CHAPLE, an ultra-rare hereditary disease that can cause potentially life-threatening gastrointestinal and cardiovascular symptoms.
Veopoz is also being evaluated in combination with Alnylam’s (ALNY - Free Report) cemdisiran (siRNAi C5 inhibitor) as an investigational combination therapy for the treatment of other complement-mediated disorders, including paroxysmal nocturnal hemoglobinuria and myasthenia gravis.
In 2019, Regeneron and Alnylam entered into a global, strategic collaboration to discover, develop and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver. In the same year, both companies entered into a license agreement for a combination consisting of cemdisiran and pozelimab. Alnylam is entitled to receive royalties on sales of the combination (if any), as well as sales milestones.
Regeneron’s shares have gained 14.6% so far this year against the industry’s decline of 14.3%.
Image Source: Zacks Investment Research
REGN is looking to diversify its revenue base. Earlier in the month, the company reported better-than-expected second-quarter 2023 results, even though lead drug Eylea’s sales declined.
The performance came on the back of the asthma drug Dupixent, for which the company has a collaboration with Sanofi (SNY - Free Report) . Dupixent maintains its stellar performance, driven by continued strong demand in the approved indications, atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis.
We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with global sales of both drugs.
Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.