Tildrakizumab
Tildrakizumab (trade name Ilumya (USA)/Ilumetri (European Union)) is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders.[1] In the United States, it is approved for the treatment of moderate-to-severe plaque psoriasis.[2]
Monoclonal antibody | |
---|---|
Type | Whole antibody |
Source | Humanized (from mouse) |
Target | IL23 |
Clinical data | |
Trade names | Ilumya |
Other names | Tildrakizumab-asmn |
Routes of administration | Subcutaneous injection |
ATC code | |
Identifiers | |
CAS Number | |
ChemSpider |
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UNII | |
KEGG | |
Chemical and physical data | |
Formula | C6426H9918N1698O2000S46 |
Molar mass | 144436.68 g·mol−1 |
Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing the immune system and autoimmune disease.
History
Originally developed by Schering-Plough, this drug became part of Merck's clinical program, following that company's acquisition of Schering-Plough.
In September 2014 Sun Pharmaceutical acquired worldwide rights to tildrakizumab for use in all human indications from Merck in exchange for an upfront payment of US$80 million. Upon product approval, Sun Pharmaceutical will be responsible for regulatory activities, including subsequent submissions, pharmacovigilance, post approval studies, manufacturing and commercialization of the approved product.[3]
As of March 2014, the drug was in phase III clinical trials for plaque psoriasis. The two trials enrolled nearly 2000 patients.[4][5]
In 2016, tildrakizumab became the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials for the treatment of moderate-to-severe plaque psoriasis, further validating the importance of the role of IL-23 in psoriasis. Sun Pharma signed a licensing pact with Spain's Almirall for marketing tildrakizumab in Europe.[6]
Approvals and indications
In March 2018, it was approved by the Food and Drug Administration for the treatment of moderate-to-severe plaque psoriasis as an injection for subcutaneous use in the United States.[2] In September 2018, it was approved by the European Commission for the treatment of adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy.[7]
See also
- Guselkumab, another experimental, IL-23-specific monoclonal antibody (FDA approved in 2017)
- Risankizumab, another experimental, IL-23-specific monoclonal antibody (FDA approved in 2019)
- Ustekinumab, a monoclonal antibody targeting both IL-12 and IL-23 and used to treat plaque psoriasis, launched in the United States under the brand name Stelara
References
- "Statement on a Nonproprietary Name Adopted by the USAN Council—Tildrakizumab", American Medical Association.
- "FDA approves Ilumya for plaque psoriasis". National Psoriasis Foundation. March 22, 2018.
- "Sun Pharma and Merck & Co. Inc. Enter into Licensing Agreement for Tildrakizumab" (Press release). Merck. 17 September 2014. Archived from the original on 12 March 2015.
- "A Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222) in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Followed by a Long-term Extension Study (MK-3222-011) - Full Text View". ClinicalTrials.gov.
- "A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants with Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010) - Full Text View". ClinicalTrials.gov.
- "Sun Pharma signs licensing pact with Spain's Almirall for tildrakizumab in Europe". Business Standard. BS B2B Bureau. 28 July 2016.
- "Almirall: The European Commission approves Almirall's ILUMETRI® (tildrakizumab) for moderate-to-severe chronic plaque psoriasis". Retrieved 23 September 2018.