Tremfya Approved for Psoriasis
July 13, 2017 – The U.S. FDA has approved Tremfya™ (guselkumab), manufactured by Janssen, for the treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic or phototherapy. Tremfya is a biologic in a new class of medications that inhibit interleukin (IL)-23. It is delivered by subcutaneous injection and will be available in prefilled 100mg/mL syringes. After the initial doses at weeks 0 and 4, it is administered every 8 weeks.
Psoriasis is a chronic immune system disease that causes an overproduction of skin cells. Plaque psoriasis, which affects approximately six million patients in the U.S., is characterized by red, scaly patches on the skin. Tremfya’s approval was based on clinical trials that demonstrated improved skin clearance compared to AbbVie’s Humira® (adalimumab), Janssen’s Stelara® (ustekinumab), and a placebo.
Janssen plans to have launched Tremfya for treatment of plaque psoriasis before the close of July 2017. The drug is currently in Phase III development for the treatment of patients who have active psoriatic arthritis, and may receive approval for this expanded indication in 2018.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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