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    Four therapeutic areas to watch in 2018


    Autoimmune disorders

    Janssen’s Tremfya (guselkumab), a biologic in a new class of medications that inhibit interleukin-23 (IL-23), was approved in July 2017 for adults with moderate to severe plaque psoriasis.

    The drug, which has a prolonged dosing interval of every eight weeks by subcutaneous injection after induction dosing, was approved based on clinical trials that demonstrated improved skin clearance compared to Humira. 

    Tremfya might be approved for an expanded psoriatic arthritis indication in 2018, says Tharaldson. 

    Other IL-23 inhibitors in the pipeline at press time include Sun Pharmaceuticals’ tildrakizumab, which is expected to be approved by March 2018, and AbbVie and Boehringer Ingelheim’s risankizumab, which might be approved in 2019.

    “IL-23 inhibitors have demonstrated strong efficacy and are expected to eventually capture a significant part of the psoriasis market,” Tharaldson says.

    Baricitinib is Incyte/Eli Lilly’s new Janus kinase (JAK) inhibitor. The RA-BEAM controlled trial, published in The New England Journal of Medicine in February 2017, shows that baricitinib, which requires only one dose daily, is superior to Humira in improving signs and symptoms in patients with rheumatoid arthritis (RA). 

    In April, the FDA sent Eli Lilly and Incyte a complete response letter for baricitinib, asking for additional clinical data to determine the most appropriate dose and more clinical data to understand the potential risk of thromboembolic events. 

    The companies responded that they will resubmit their application for approval by the end of January 2018 and hope to be off and running by next summer.

    AbbVie also has a JAK inhibitor, upadacitinib, which may be approved for RA in 2019.

    Gleason is concerned that these drugs will not result in a value payout from medical offset because patients with autoimmune diseases are plagued by several other conditions and by the drugs’ high prices.


    Next: COPD


    Mari Edlin
    Mari Edlin is a frequent contributor to Managed Healthcare Executive. She is based in Sonoma, California.


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