Regeneron made a surprise announcement on Thursday that the FDA was poised to make a decision on a higher dose regimen of Eylea (aflibercept) in the third quarter of this year – far ahead of the expected timeline. This could potentially be a huge game-changer for the market and millions of patients who rely on Eylea.
In June 2023, devastating news arrived for Regeneron as the regulator refused their application for an 8-mg dose of Eylea when given at a 12-week or 16-week interval. The FDA’s Complete Response Letter was alarming in that it didn’t mention any problems with safety or efficacy, nor did it raise any questions about labelling, trial design, or drug substance manufacturing. Rather, this impromptu inspection of a third-party contractor’s vial-filling practices led to the FDA’s ultimate decision.
Regeneron is pressing ahead with plans to get the extra data needed to secure US approval of its drug, with the help of Catalent, an external service provider. After a rapid response from the FDA, Regeneron is hopeful that the submission will be reviewed and a decision made by the end of the third quarter.
“Regeneron CEO Leonard Schleifer announced in an investor call Thursday morning that the FDA has promised to work expeditiously to finish the review process, though they may utilize a three month extension period if necessary. Schleifer noted that the FDA will remain dedicated to prioritizing the review and will complete it as soon as possible.”
Investors reacted positively to the news, sending the company’s shares up 2.6% in premarket trading Thursday.
Eylea’s second quarter revenue for Regeneron came in at $1.5 billion, down 7% from last year’s $1.62 billion. Despite suffering a slight setback in the period, there’s hope for Eylea due to its recent approval of a new treatment option that would enable patients to better adhere to their care plans. If successful, this could help regenerate Eylea’s sales.
Eylea, Regeneron’s revolutionary eye injection, has been proven to be a giant leap in treating many eye conditions, including wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and macular edema after retinal vein occlusion. This fusion protein blocks both VEGF-A and PLGF, resulting in an effective and reliable treatment for these conditions.
Regeneron’s Eylea has revolutionized wet AMD treatment, offering a safe and effective 2-mg dose that is administered monthly. Now, Regeneron is taking things one step further with the investigational 8-mg formulation. Data from two pivotal studies reveal this new regimen is just as safe and effective as the approved schedule, but even easier for patients to maintain – potentially allowing Eylea to be administered every 12 or 16 weeks!
Despite a 7% decline in sales for Eylea, Regeneron managed to beat analysts’ expectations for the second quarter by reporting total revenues of close to $3.16 billion— up 11% from its $2.86 billion earnings during the same period last year. This impressive performance was buoyed by encouraging gains in its skin cancer treatment Libtayo (cemipilimab), cardio asset Praluent (alirocumab) and homozygous familial hypercholesterolemia medicine Evkeeza (evinacumab).
Thanks to Revenue from Sanofi, Regeneron’s financial performance saw a remarkable leap in the second quarter. Most notably, their earnings from Sanofi soared 39% with the help of Dupixent, the allergy medicine developed in partnership between the two companies. Dupixent recorded a 33% increase in sales compared to last year, bringing in an incredible $2.79 billion. A remarkable achievement!
Regeneron reported during its second-quarter report that unfortunate events occurred during an early-stage cancer study. Two patients receiving a combination of full-dose Libtayo and REGN5678, an investigational costimulatory bispecific antibody, passed away. As an immediate consequence, enrollment into this arm of the treatment has been discontinued and further investigation about combining REGN5678 with lower doses of Libtayo is ongoing.