UCB Korea's plaque psoriasis treatment receives approval

UCB Korea said its dual inhibitor targeting interleukin-17A and 17F, Bimzelx (ingredient: bimekizumab), has been approved by the Ministry of Food and Drug Safety (MFDS) for the treatment of moderate-to-severe plaque psoriasis in adults who require phototherapy or systemic therapy.

The Ministry of Food and Drug Safety approved UCB Korea's plaque psoriasis treatment, Bimzelx. (Credit: Getty Images)

According to UCB, Bimzelx is the first and only treatment for plaque psoriasis that simultaneously inhibits IL-17A and IL-17F, cytokines that play a central role in the inflammatory process associated with psoriasis.

The dual action allows Bimzelx to selectively and directly target these cytokines, providing a new therapeutic option in the management of the disease.

The MFDS approved the drug based on the company's phase 3 clinical trials, including long-term studies.

Notably, in the BE READY study, which compared Bimzelx to a placebo, 90.8 percent of patients treated with Bimzelx achieved PASI 90 (a 90 percent improvement in the Psoriasis Area and Severity Index) by week 16, and 68.2 percent reached PASI 100, indicating completely clear skin.

Additionally, 92.6 percent of patients in the Bimzelx group achieved an Investigator's Global Assessment (IGA) score of zero or one, significantly higher than the 1.2 percent observed in the placebo group.

Bimzelx also showed superiority was further demonstrated in comparative trials against other biologics, including ustekinumab, adalimumab, and secukinumab.

Long-term efficacy was confirmed in the BE BRIGHT open-label extension study, where 82 percent of patients who achieved PASI 100 at week 16 maintained this response for up to three years.

"Psoriasis is an immune-mediated inflammatory disease that significantly affects both physical and mental health," Korean Society for Psoriasis President Choe Yong-beom said. "The stress associated with this condition is comparable to that seen in patients with heart disease, diabetes, cancer, or depression."

The approval of a treatment with a novel mechanism of action is a significant step forward in addressing the unmet medical needs in psoriasis care, Choe added.

UCB Korea CEO Hwang Su-jin also said, "We are delighted that Bimzelx has been approved in Korea, providing a new therapeutic option for patients with moderate-to-severe plaque psoriasis."

The long-term benefits demonstrated in clinical trials underscore the potential of Bimzelx to improve the quality of life for psoriasis patients, Hwang added.