Too Little, Too Late For GSK/Janssen's Sirukumab in RA?
Full data for the Phase III SIRROUND-D study of GlaxoSmithKline PLC/Janssen Pharmaceuticals Inc.'s sirukumab show early and good separation over placebo in rheumatoid arthritis, but the third-placed anti-IL6 product will have to work hard to catch up with its more advanced rivals, Actemra (tocilizumab) and sarilumab.
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Unfavorable trends in all-cause death, malignancy and major adverse cardiovascular events are key safety issues facing US agency's Arthritis Advisory Committee, which also is being asked to weigh adequacy of Janssen's dose selection and, more generally, use of long-term placebo controls in rheumatoid arthritis studies.
At ACR: Janssen reported data that show Celltrion’s Remicade biosimilar is not quite the same, but positive sirukumab results may not boost the Janssen and GSK biologic’s market prospects. Meanwhile, Corbus surged on mid-stage resunab results in systemic sclerosis, Janssen shared Phase II gesulkumab psoriasis results, Genentech eyes a new Actemra indication, and Xencor rose on interim Phase II data.
GlaxoSmithKline is working to establish an immuno-inflammation portfolio and extend learnings to other therapy areas. Sirukumab could be GSK's first new product in I&I beyond Benlysta. Chief Immunology Officer Paul-Peter Tak outlined his strategy in an interview with Scrip.