- Sanofi and Regeneron's promising IL-6 antibody sarilumab demonstrated greater efficacy than AbbVie's market-leading Humira in a phase 3 study, the company said on Friday.
- The study is not part of the FDA's regulatory review of the drug, however. Sanofi previously submitted the rheumatoid arthritis (RA) drug to the FDA for approval in January. The FDA's target action date is October 30, 2016.
- Humira (adalimumab) continues to rake in sales, earning just over $14 billion in global sales in 2015. While there was substantial growth over 2014 sales, Humira's patent is close to expiring—threatening AbbVie's dominant position.
Even with demonstrated superiority, sarilumab will face a crowded filed in the RA market with Roche, GlaxoSmithKline, and Johnson & Johnson also developing treatments.
The study, known as SARIL-RA-MONARCH, improved signs and symptoms in patients with rheumatoid arthritis after 24 weeks of treatment. Participants were divided into two groups receiving an injection of either sarilumab (200 mg) or Humira (40 mg) every two weeks.
"This is the first time an IL-6 receptor blocker delivered subcutaneously has demonstrated superiority over adalimumab monotherapy in RA," said Janet van Adelsberg, a senior director at Regeneron.
AbbVie's Humira has been one of the top-selling drugs in the world, but will technically lose patent protection in December 2016. Amgen has already filed a biosimilar, ABP 501, with the FDA.