Ilumya Approved to Treat Plaque Psoriasis
March 21, 2018 – The U.S. FDA has approved Ilumya™ (tildrakizumab-asmn), manufactured by Sun Pharma, for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy.
An estimated six million individuals in the United States live with plaque psoriasis, a chronic immune disorder in which overproduction of skin cells leads to raised, red patches of skin on various parts of the body. The patches can become painful and subject to cracking and bleeding.
The latest in a new class of drugs known as interleukin-23 (IL-23) inhibitors, Ilumya works by selectively blocking a cytokine involved in the immune system’s inflammatory response. Recommended dosing is 100mg in Week 0, Week 4, and then every 12 weeks following. Ilumya will be available in single-use, prefilled syringes for subcutaneous injection.
Janssen’s Tremfya® (guselkumab), approved in July of 2017, was the first IL-23 inhibitor to reach the U.S. market. An additional IL-23 inhibitor, risankizumab, is currently in development with Boehringer Ingelheim and AbbVie, and may be approved in 2019.
Sun Pharma has not yet released pricing information for Ilumya. The product is expected to launch in June or July of 2018.
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- 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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