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FDA Approves Ilumya for Plaque Psoriasis

Sun Pharmaceutical Industries Ltd. news release; 2018 Mar

Sun Pharmaceutical Industries Ltd. (Sun Pharma) has announced that the US Food and Drug Administration (FDA) has approved Ilumya (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Sun Pharma is headquartered in Mumbai, India, and Princeton, NJ.

Indications: Ilumya selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of pro-inflammatory cytokines and chemokines.

Dosage/administration: Ilumya is administered at a dose of 100 mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4. It is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

Adverse reactions: The most common (≥1%) adverse reactions associated with Ilumya treatment are upper respiratory infections, injection site reactions, and diarrhea.

Citation:

Sun Pharma announces US FDA approval of ILUMYA™ (tildrakizumab-asmn) for the treatment of moderate-to-severe plaque psoriasis. [news release]. Mumbai, India and Princeton, NJ: Sun Pharmaceutical Industries Ltd. March 21, 2018. file:///C:/Users/mkelly/Downloads/Sun%20Pharma%20Announces%20U.S.%20FDA%20Approval%20of%20ILUMYA%20(2).pdf. Accessed March 22, 2018.