Tildrakizumab
- Generic Name
- Tildrakizumab
- Brand Names
- Ilumya, Ilumetri
- Drug Type
- Biotech
- CAS Number
- 1326244-10-3
- Unique Ingredient Identifier
- DEW6X41BEK
- Background
Tildrakizumab is a high-affinity, humanized, IgG1 κ antibody targeting interleukin 23 p19 that shows promise in the evolution of treatment strategy in chronic plaque psoriasis .
The Food and Drug Administration (FDA) approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy in March 2018. The approved recommended dosage of ILUMYA is a subcutaneous injection of 100 mg at Weeks 0, 4, and every 12 weeks thereafter .
A study was performed on the pharmacokinetics of this drug on various ethnicities. The pharmacokinetics of tildrakizumab were similar in Japanese, Caucasian, and Chinese subjects .
- Indication
Moderate-severe plaque psoriasis , .
- Associated Conditions
- Moderate to Severe Plaque Psoriasis
Trump's Executive Order Delays Medicare Drug Price Negotiations, Sparking Industry and Policy Debate
• President Trump signed an executive order extending the exemption period for small-molecule drugs from Medicare price negotiations by four years, a move criticized by advocacy groups as favoring pharmaceutical industry interests.
• The order aims to address what the administration calls the "pill penalty" - the current policy where small-molecule drugs (90% of medications) face negotiations after 9 years while biologics have longer exemption periods.
• The Medicare Drug Price Negotiation Program, established under the Biden administration, had already achieved price reductions of 38-79% on 10 high-cost drugs with projected savings of $6 billion if applied in 2023.
Sun Pharma's Leqselvi Advances Toward Launch After Favorable US Court Ruling
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• Emkay Research projects Leqselvi could generate over $500 million in global sales by FY30, with initial US sales of $40 million expected in FY26, positioning it as a cornerstone specialty product with EBITDA margins exceeding 45%.
• The brokerage firm has issued a "BUY" recommendation for Sun Pharma with a target price of Rs 2,400, representing a potential 45% upside from current levels, citing strong product pipeline and consistent execution on specialty drug launches.
FDA Approves Lilly's Omvoh (mirikizumab) for Crohn's Disease
• The FDA has approved Eli Lilly's Omvoh (mirikizumab-mrkz) for treating moderately to severely active Crohn's disease in adults, expanding its use for inflammatory bowel disease.
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• Omvoh is the first biologic in over 15 years with Phase 3 two-year efficacy data at launch, demonstrating long-term disease control and visible healing of the intestinal lining.
• Lilly has submitted marketing applications globally, aiming to provide a new treatment option for Crohn's patients and is working with insurers to enable patient access.
Johnson & Johnson Seeks FDA Approval for Tremfya to Treat Pediatric Psoriasis and Arthritis
• Johnson & Johnson has submitted sBLAs to the FDA for Tremfya (guselkumab) to treat moderate-to-severe plaque psoriasis in children aged 6 and older.
• The submission also seeks approval for Tremfya to treat active juvenile psoriatic arthritis in children aged 5 and older.
• The sBLAs are based on data from the Phase 3 PROTOSTAR study and pharmacokinetic data from adult studies VOYAGE 1 and 2, and DISCOVER 1 and 2.
• Tremfya, an IL-23 inhibitor, is already approved for adults with plaque psoriasis, psoriatic arthritis, and ulcerative colitis.
J&J's Oral IL-23 Inhibitor Icotrokinra Achieves Positive Phase 3 Results in Psoriasis
• Johnson & Johnson's icotrokinra met primary endpoints in the ICONIC-LEAD phase 3 trial, demonstrating significant skin clearance in psoriasis patients.
• After 16 weeks, 64.7% of patients achieved clear or almost clear skin (IGA 0/1), and 49.6% showed a 90% or greater improvement in PASI score.
• Icotrokinra's tolerability profile was consistent with previous phase 2 studies, with similar adverse event rates compared to placebo.
• J&J plans to submit icotrokinra for regulatory approval, positioning it as a potential oral alternative to injectable biologics for psoriasis.
Drug Development Updates
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