US FDA red light for Janssen’s arthritis mAb
Spokesperson Brian Kenney told us the US Food and Drug Administration (FDA) requires additional clinical data in order to reassess the firm’s Biologics License Application (BLA).
“The complete response letter [CRL] indicates that additional clinical data are needed to further evaluate the safety of sirukumab in the treatment of moderately to severely active RA,” said Kenney.
Head of immunology development, Newman Yeilding, said the firm is disappointed with the result.
“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.”
“We believe sirukumab represents an important therapeutic option for patients living with rheumatoid arthritis,” he said.
Kenney told us the firm, which is owned by Johnson & Johnson, plans to meet with the FDA to discuss the BLA.
“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”, he said.
The sirukumab story
Sirukumab – a fully human monoclonal IgG1 kappa antibody – is designed to selectively inhibit circulating, naturally occurring proteins known as interleukin (IL)-6. According to Jannsen, this protein is believed to contribute to autoimmune conditions like the systemic inflammatory condition, RA.
Janssen and GlaxoSmithKline (GSK) entered into a licensing and co-development agreement for sirukumab in December, 2011, allowing GSK exclusive rights to commercialise the mAb across the Americas.
On July 26 this year, GSK announced it had decided to terminate its collaboration on sirukumab with Janssen.
Janssen, as the regulatory sponsor for sirukumab in the US, submitted the sirukumab BLA on September 23, 2016.
The FDA’s Arthritis Advisory Committee announced it did not recommend approval for the mAb on August 2, 2017.
