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Secukinumab

Generic Name
Secukinumab
Brand Names
Cosentyx
Drug Type
Biotech
CAS Number
1229022-83-6
Unique Ingredient Identifier
DLG4EML025

Overview

Secukinumab is a fully human monoclonal IgG1/κ antibody against interleukin-17A (IL-17A), a proinflammatory cytokine implicated in various chronic immune-mediated inflammatory disorders, such as plaque psoriasis. By blocking the actions of IL-17A, secukinumab works to inhibit the pro-inflammatory pathways that drive immune-mediated inflammatory disorders. Following its first global approval in Japan in December 2014, secukinumab was approved by the European Commission on January 15, 2015, and by the FDA a few days after (January 21, 2015). It is currently approved to treat a number of chronic inflammatory conditions, such as plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

Background

Secukinumab is a fully human monoclonal IgG1/κ antibody against interleukin-17A (IL-17A), a proinflammatory cytokine implicated in various chronic immune-mediated inflammatory disorders, such as plaque psoriasis. By blocking the actions of IL-17A, secukinumab works to inhibit the pro-inflammatory pathways that drive immune-mediated inflammatory disorders. Following its first global approval in Japan in December 2014, secukinumab was approved by the European Commission on January 15, 2015, and by the FDA a few days after (January 21, 2015). It is currently approved to treat a number of chronic inflammatory conditions, such as plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis.

Indication

Secukinumab is indicated the treatment of moderate to severe plaque psoriasis in patients six years and older who are candidates for systemic therapy or phototherapy. In Europe, the drug is used in children and adolescents six to 18 years of age for this indication. It is also indicated for the treatment of active psoriatic arthritis (PsA). In the US, it is approved for patients two years of age and older while in Europe, it is used alone or in combination with methotrexate in patients six years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. Secukinumab is also indicated in the treatment of active enthesitis-related arthritis (ERA). In the US, it is approved for patients four year of age and older. In Europe, it is used alone or in combination with methotrexate in patients six years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy. In the US, secukinumab is indicated for the treatment of adults with active ankylosing spondylitis or non-radiographic axial spondyloarthritis with objective signs of inflammation.

Associated Conditions

  • Enthesitis Related Arthritis (ERA)
  • Juvenile Idiopathic Arthritis (JIA)
  • Juvenile psoriatic arthritis
  • Non-radiographic Axial Spondyloarthritis
  • Severe Plaque psoriasis
  • Active Ankylosing spondylitis
  • Active Psoriatic arthritis
  • Moderate Plaque psoriasis

FDA Approved Products

COSENTYX
Manufacturer:Novartis Pharmaceuticals Corporation
Route:INTRAVENOUS
Strength:25 mg in 1 mL
Approved: 2023/10/06
NDC:0078-1168
COSENTYX
Manufacturer:Novartis Pharmaceuticals Corporation
Route:SUBCUTANEOUS
Strength:75 mg in 0.5 mL
Approved: 2023/10/06
NDC:0078-1056
COSENTYX
Manufacturer:Novartis Pharmaceuticals Corporation
Route:SUBCUTANEOUS
Strength:300 mg in 2 mL
Approved: 2023/10/06
NDC:0078-1070
COSENTYX
Manufacturer:Novartis Pharmaceuticals Corporation
Route:SUBCUTANEOUS
Strength:150 mg in 1 mL
Approved: 2023/10/06
NDC:0078-0639

Singapore Approved Products

COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 75MG/0.5ML
Manufacturer:Novartis Pharma Stein AG
Form:INJECTION, SOLUTION
Strength:75.0mg/0.5ml
Online:Yes
Approved: 2021/09/01
Approval:SIN16315P
COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 150MG/ML
Manufacturer:Novartis Pharma Stein AG, Sandoz GmbH (manufacturing, primary packaging and QC testing)
Form:INJECTION, SOLUTION
Strength:150 mg/ml
Online:Yes
Approved: 2015/03/13
Approval:SIN14751P
COSENTYX SOLUTION FOR INJECTION IN PREFILLED SYRINGE 300MG/2ML
Manufacturer:Novartis Pharma Stein AG
Form:INJECTION, SOLUTION
Strength:300.0 mg/2ml
Online:Yes
Approved: 2021/11/02
Approval:SIN16358P
COSENTYX SOLUTION FOR INJECTION IN PRE-FILLED UNOREADY PEN 300MG/2ML
Manufacturer:Novartis Pharma Stein AG
Form:INJECTION, SOLUTION
Strength:300.0mg/2ml
Online:Yes
Approved: 2021/11/02
Approval:SIN16359P
COSENTYX SOLUTION FOR INJECTION IN PREFILLED SENSOREADY PEN 150MG/ML
Manufacturer:Novartis Pharma Stein AG, Sandoz GmbH
Form:INJECTION, SOLUTION
Strength:150 mg/ml
Online:Yes
Approved: 2015/03/13
Approval:SIN14750P

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