EMA backs approval for J&J's Tremfya
- Johnson & Johnson's plans for its new psoriasis drug Tremfya got a lift Friday, with a key committee of the European Medicines Agency recommending approval of the antibody in adults with moderate to severe plaque psoriasis. Tremfya was approved in the U.S. for the same indication earlier this year.
- The pharma giant filed Tremfya for approval based on two studies comparing Tremfya with placebo and AbbVie, Inc.'s top-selling market leader Humira. A final decision from the European Commission is expected later this year.
- Data presented over the weekend from an open-label extension study further solidified Tremfya's efficacy, showing over 80% of people treated with the IL-23 inhibitor experienced at least a 90% improvement in the Psoriasis Area Severity Index (PASI 90) at two years.
As well as being itchy and painful, plaque psoriasis can result in thick, red and scaly marks, leaving people with the condition uncomfortable about exposing their skin. The psychological impact can be similar to that seen in cancer, heart disease and depression, according to data cited by J&J's pharma unit Janssen Pharmaceutical.
"People living with plaque psoriasis bear a tremendous physical and emotional burden due to the painful and visible nature of the disease, and there is a real need to improve upon current treatment options," said José Antonio Burόn Vidal, head of medical affairs for Janssen in Europe, Middle East and Africa.
That need has sustained continued investment from pharma companies into the development of new treatments.
Tremfya (guselkumab) is an anti-IL-23 monoclonal antibody that is self-administered every eight weeks. Approval by the Food and Drug Administration in July put it into competition with a crowded class of therapeutics addressing psoriasis.
In addition to mainstay TNF inhibitors like Humira (adalimumab), more recently approved therapies such as Novartis AG's Cosentyx (secukinumab) and Eli Lilly & Co.'s Taltz (ixekizumab) have expanded the number of treatment options for the condition.
New evidence from the VOYAGE 1 study presented at last weekend's annual meeting of the European Academy of Dermatology and Venereology Congress gave further evidence of Tremfya's efficacy vis a vis Humira. Skin clearance rates in patients who had initially been randomized to Humira treatment, and then subsequently transitioned to Tremfya after one year, improved over the next 48 weeks.
J&J plans to continue development of Tremfya, with the ECLIPSE study comparing the drug to Cosentyx and other trials looking at psoriatic arthritis and Crohn's disease.
- Johnson & Johnson Press release
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