With a near-certain approval of Regeneron Pharmaceuticals'
In a phase 2b trial, the drug proved successful in treating rheumatoid arthritis, with 72% of patients taking the higher dose in combination with methotrexate reporting at least a 20% improvement in symptoms. Only 46% of patients taking methotrexate alone reported the same level of improvement. A lower dose had a modest and probably meaningless increase with 49% of patients reporting at least a 20% improvement.
In a separate trial, Regeneron and partner Sanofi said that sarilumab failed to show an effect in patients with another autoimmune disease called ankylosing spondylitis. It looks like sarilumab is off to a phase 3 in just rheumatoid arthritis.
But the phase 3 trial might not be the biggest hurdle for sarilumab. Like Eylea, which will compete with Roche's Lucentis and Avastin, sarilumab will hit plenty of competition if it makes it to market.
To make a dent in the market, sarilumab needs to have better efficacy than the established autoimmune players that target TNF: Merck
Sarilumab targets a different molecule, the IL-6 receptor, but competition is heating up there, too. Roche's Actemra is already approved, and Alder Biopharma and Bristol-Myers Squibb
If you add in potential oral rheumatoid arthritis medications from Pfizer and others, Regeneron and Sanofi look like they'll need out-of-this-world data for sarilumab for sales to amount to much.
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