Tildrakizumab

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Tildrakizumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized (from mouse)
TargetIL23
Clinical data
Trade namesIlumya
SynonymsTildrakizumab-asmn
Routes of
administration
Subcutaneous injection
ATC code
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6426H9918N1698O2000S46
Molar mass144.4 kg/mol g·mol−1

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]

Tildrakizumab was designed to block interleukin-23, a cytokine that plays an important role in managing the immune system and autoimmune disease.

History[edit]

Originally developed by Schering-Plough, this drug became part of Merck's clinical program, following that company's acquisition of Schering-Plough.[when?]

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 U.S. $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[edit]

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[edit]

  • 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
  • Guselkumab, another experimental, IL-23-specific monoclonal antibody (FDA approved in 2017)
  • Risankizumab, another experimental, IL-23-specific monoclonal antibody (In Phase 3 clinical trials for plaque psoriasis as of 2017)

References[edit]

  1. ^ "Statement on a Nonproprietary Name Adopted by the USAN Council—Tildrakizumab", American Medical Association.
  2. ^ a b "FDA approves Ilumya for plaque psoriasis". National Psoriasis Foundation. March 22, 2018.
  3. ^ "Merck Licensing - Press Release". www.merck.com. 17 September 2014.
  4. ^ "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". clinicaltrials.gov.
  5. ^ "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". clinicaltrials.gov.
  6. ^ Bureau, BS B2B (28 July 2016). "Sun Pharma signs licensing pact with Spain's Almirall for tildrakizumab in Europe" – via Business Standard.
  7. ^ "Almirall: The European Commission approves Almirall's ILUMETRI® (tildrakizumab) for moderate-to-severe chronic plaque psoriasis". Retrieved 23 September 2018.