Regeneron’s Eylea trumps rivals in NIH study

Regeneron is claiming victory after a US-government sponsored trial has suggested its eye treatment Eylea is superior to its rivals in treating diabetic macular oedema.

The US company has seized on the study sponsored by the US National Institutes of Health (NIH), which has not yet been publicly presented.

The three-way study examined the safety and effectiveness of Novartis’ Lucentis and Regeneron/Bayer’s Eylea, both licensed to treat diabetic macular oedema (DME) and Roche/Genentech’s Avastin, which is frequently used off-label to treat this and related conditions.

The original impetus behind the trial is the frequent off-label use of Avastin (bevacizumab) in these patients. Ophthalmologists have been using the drug off-label for years, as it is virtually the same molecule as Lucentis (ranibizumab), but is far cheaper than Lucentis when used in these patients.

Both Novartis and Roche/Genentech (who developed and licensed Lucentis to Novartis) have steadfastly opposed this use of Avastin, claiming its safety and efficacy profile is inferior to Lucentis when adapted for use in eye patients.

The row over Avastin’s use has escalated in the last few years, with Novartis threatening legal action against one UK health authority which advocated its use, the company eventually settling out of court. Earlier this year, France’s anti-trust watchdog raided Roche and Novartis seeking evidence of collusion.

The independent, NIH-sponsored study of 660 patients was undertaken by the Diabetic Retinopathy Clinical Research Network (DRCR.net), and was designed to see if one of the treatments was superior in treating DME.

DRCR.net has shared the top-line results with study investigators, and is finalising the data prior to submission for publication and presentation at a medical congress.

Regeneron will clearly be trying to spread the word among ophthalmologists and health care payers, as it seeks to gain market share from Novartis.

“The National Eye Institute and The National Institute of Diabetes and Digestive and Kidney Diseases of the NIH and the DRCR.net should be commended for a carefully designed and well-conducted study,” said George D. Yancopoulos, M.D., Ph.D., chief scientific officer and president of Regeneron’s R&D division. “These data will provide useful information to retinal specialists and their patients to help guide treatment decisions.”

Novartis has also responded to the top line results emerging from the trial, but did not comment directly on the findings, and says it awaits publication of the full results and further analysis.

Lucentis is the market leader, with sales of $4.18 billion last year, but its growth is slowing due to pressure from off-label Avastin and the arrival of Eylea.

The primary indication for Lucentis is wet age-related macular degeneration (wet AMD) but Novartis has successfully expanded its indications, with Eylea in hot pursuit.

Regeneron and Bayer launched Eylea in 2012, and the drug has proved to be an immediate success, rising to $1.88 billion in global earnings in 2013.

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