Celltrion Healthcare Canada Limited has announced that Steqeyma® (ustekinumab injection) and Steqeyma® I.V. (ustekinumab for injection, solution for intravenous infusion) have been approved by Health Canada. These medications are now authorized for treating adults with moderately to severely active Crohn’s disease, moderate to severe plaque psoriasis, and active psoriatic arthritis.

Jungyong Shin, Managing Director at Celltrion Healthcare Canada, remarked, "We are excited to add Steqeyma to our offerings, which strengthens our position in immunology. This approval reflects our commitment to providing accessible, high-quality biologic treatments."

The approval was supported by evidence from a Phase III study, where the primary outcome was the change in Psoriasis Area and Severity Index (PASI) for skin symptoms. Results showed that Steqeyma's efficacy was similar to Stelara, the reference product, over 52 weeks for moderate-to-severe plaque psoriasis. Patients who switched from Stelara to Steqeyma at Week 16 had comparable results in efficacy and safety as those who remained on Stelara. Steqeyma was found to be well-tolerated, with no significant safety issues compared to Stelara.

Dr. Kim Alexander Papp, MD, PhD, from Probity Medical Research in Waterloo and the University of Toronto, commented, “Plaque psoriasis and psoriatic arthritis are serious inflammatory diseases that can severely impact quality of life. With around 1 million Canadians affected by psoriasis, the introduction of Steqeyma offers a promising new option for managing these chronic conditions.”

Steqeyma® and Steqeyma® I.V. are designed to target IL-12 and IL-23 for treating various immune-mediated conditions. They are approved for use in treating active psoriatic arthritis (PsA) and Crohn’s disease (CD) in adults, as well as plaque psoriasis (PsO). Steqeyma is available in subcutaneous and intravenous forms. The subcutaneous injection comes in 45mg/0.5 mL or 90mg/1 mL strengths, provided in a prefilled syringe. The intravenous infusion is available as a 130mg/26 mL solution in a single-dose vial.

 

Source: businesswire.com

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