FDA rejects J&J’s treatment for rheumatoid arthritis
pharmafile | September 25, 2017 | News story | Sales and Marketing | Johnson & Johnson, biotech, drugs, pharma, pharmaceutical, sirukumab
Perhaps unsurprisingly, after the FDA’s advisory committee had voted 12-1 against approval of Johnson & Johnson’s drug, the FDA returned to the company with a rejection of its rheumatoid arthritis treatment.
Sirukumab had once been considered a sure-fire blockbuster for the company, but such hopes floundered after the advisory committee returned their resounding rejection and partner to the drug, GSK, abandoned ship.
The reason for the rejection of the drug in front of the advisory committee came down to the safety profile of the drug. Of the 35 deaths that occurred during the clinical trials of the treatment, 34 of these were in patients who had been receiving sirukumab. J&J insisted that this was not indicative of the overall safety profile of the treatment, but it was not enough to convince the FDA.
The drug, sirukumab, is a fully human monoclonal IgG1 kappa antibody that selectively blocks circulating interleukin. It would have joined two other such drugs on the market, Roche’s Actemra and Saonfi’s Kevzara, if it had been approved. However, the fact that there are already two similar treatments without the worrying safety profile more than likely counted against J&J in its case for approval.
“We are disappointed by this development as we feel the data accumulated to date support the efficacy and safety of sirukumab in the treatment of moderately to severely active rheumatoid arthritis,” said Newman Yeilding, Head of Immunology Development, Janssen Research & Development.
He continued, “We believe sirukumab represents an important therapeutic option for patients living with rheumatoid arthritis, especially for those individuals who cycle through multiple treatments and continue to struggle to find an effective option for a potentially disabling disease. 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 US approval.”
It is understood that J&J would need to return to the FDA with further safety data on the drug that was more reassuring of its benefit/risk balance. Whether J&J will decide to do this whilst its competitors continue to cement their position in the market place remains to be seen.
Ben Hargreaves
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