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FDA wants more data on J&J’s arthritis drug Plivensia

Requests further evidence on the drug’s safety profile after patient deaths link


As expected, the FDA has rejected Johnson & Johnson’s Plivensia for rheumatoid arthritis, backing the decision delivered by its advisory committee in August.

The complete response letter (CRL) sent by the US regulator says that additional clinical data will be needed to support approval, suggesting that it wants further evidence of the drug’s safety after its advisors highlighted a higher of number deaths in patients treated with the drug rather than placebo in trials, mainly from cardiovascular problems, infections and cancer.

Depending on the scale of the trial needed, J&J could face a considerable delay before it can bring Plivensia (sirukumab) to market, dampening the commercial prospects for the drug and giving time for other new RA therapies to make headway.

Investors seemed to have fully acknowledged the difficult road ahead for Plivensia, as shares in J&J were unmoved by the news of the FDA’s decision.

J&J sought approval of sirukumab as a treatment for adults with moderate to severe RA - who respond inadequately to or cannot tolerate one or more disease-modifying anti-rheumatic drugs (DMARDs) such as methotrexate. The drug was filed for approval in Europe last September and is still awaiting a verdict from the CHMP.

An IL-6 inhibitor, Plivensia would compete with other drugs in the class, namely Roche’s well-established Actemra (tocilizumab) and Sanofi/Regeneron’s new entrant Kevzara (sarilumab), which claimed its first approvals earlier this year. Actemra made sales of $1.7bn last year, but is expected to see strong competition from Kevzara, which has been launched at a discount to its rival and requires less frequent dosing.

Meanwhile, the RA market is set to be shaken up by the continued roll-out of lower-priced biosimilars to the first generation of anti-TNF biosimilar drugs, as well as the roll-out of additional drugs in the JAK inhibitor class, with Pfizer’s Xeljanz (tofacitinib) recently joined by Eli Lilly’s Olumiant (baricitinib) in the EU (but delayed in the US), and with candidates from AbbVie and Gilead/Galapagos in late-stage development.

Newman Yeilding, head of immunology development at J&J’s Janssen subsidiary, said the company was “disappointed by this development as we feel the data accumulated to date support the efficacy and safety of [Plivensia] in the treatment of moderately to severely active RA".

He added: "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."  At this point Plivensia had also been viewed as a potential blockbuster.

The troubles besetting Plivensia makes the decision by J&J’s former partner for the drug GlaxoSmithKline (GSK) to drop the drug earlier this year look like a prescient move.

Article by
Phil Taylor

25th September 2017

From: Regulatory



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