Following negative adcomm, J&J's sirukumab rejected
- Janssen Biotech, a Johnson & Johnson company, announced Friday it has received a complete response letter from the Food and Drug Administration for its rheumatoid arthritis candidate sirukumab.
- This follows a 12-1 vote taken last month by an FDA advisory panel recommending against approval. The committee, whose advice the FDA usually follows, said the benefits of the IL-6 antibody did not outweigh its safety risks.
- In its rejection letter, the FDA requested additional clinical data so as to re-evaluate the safety of the drug in this indication.
"We are reviewing the details of the complete response letter and plan to have a follow-up discussion with the agency to gain a full understanding of FDA requirements for U.S. approval," said Newman Yeilding, head of immunology development at Janssen R&D, in a statement.
This rejection makes it less likely that sirukumab, which was submitted for approval in Europe and the U.S. in September 2016, will meet the company's prediction of blockbuster status any time soon — if ever. The drug was meant to be a linchpin in the company's immunology portfolio.
J&J's top-selling drug is the TNF-inhibitor Remicade (infliximab). But the drug faces competition from multiple biosimilars, turning new focus to the pharma giant's pipeline. While sales of Remicade have not been hurt just yet, these competitors are likely to gain traction in coming years as biosimilars become a larger part of the U.S. treatment landscape.
Back in November 2016, results from one of the five Phase 3 studies presented at the annual meeting of the American College of Rheumatology showed that while sirukumab was better at reducing inflammatory blood markers than AbbVie's Humira (adalimumab), it wasn't significantly better at reducing signs and symptoms of the disease. The rates of adverse events were also higher for sirukumab than Humira.
Janssen held exclusive rights to sirukumab in Europe, the Middle East, Africa and Asia Pacific, and licensed other rights to GlaxoSmithKline. However, sirukumab was one of the 30 programs culled by the British pharma earlier this year. Janssen retained rights to the drug, originally developed by Centocor Ortho Biotech.
- Janssen Biotech Statement
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