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Oluwatobiloba Jaiyeola
The United States Food and Drug Administration has approved a new oral medication called Sotyktu (deucravacitinib) for the treatment of moderate-to-severe plaque psoriasis in adults.
The drug, manufactured by an American multinational pharmaceutical company, Bristol Myers Squibb is a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor and is not recommended for use in combination with other potent immunosuppressants.
Psoriasis, according to Mayo Clinic – a medical center focused on integrated health care, education, and research is a skin disease that causes a rash with itchy, scaly patches, commonly on the knees, elbows, trunk, and scalp.
It is a common, chronic long-term disease with no cure and can be painful. It can also interfere with sleep and make it hard to concentrate.
Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease. The most common form of psoriasis is plaque psoriasis.
The chief medical officer at Bristol Myers Squibb, Samit Hirawat said, “The approval of Sotyktu represents an exciting day for patients suffering from moderate-to-severe plaque psoriasis who are not satisfied with topical and conventional treatments.
“This is another extraordinary achievement for Bristol Myers Squibb, as we bring forward a new mechanism of action, the first oral treatment approved in nearly 10 years, and the first orally dosed once-daily treatment for moderate-to-severe plaque psoriasis.”
“We believe Sotyktu is a breakthrough in the treatment of patients with this condition, and we’re excited about its potential in other immune-mediated diseases,” he added.
According to the manufacturing company, the approval is based on results from the pivotal Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials.
The results were said to have demonstrated superior efficacy of once-daily Sotyktu in comparison to placebo and twice-daily Otezla (apremilast) in 1,684 patients aged 18 years and above with moderate-to-severe plaque psoriasis.
The superior efficacy of Sotyktu compared to placebo and Otezla was demonstrated at both 16 and 24 weeks, and responses with Sotyktu persisted through 52 weeks, Bristol Myers Squibb said.
Clinical investigator in the POETYK PSO-1 trial and Associate Dean and Professor of Dermatology at the University of Southern California, April Armstrong said, “Sotyktu has the potential to become the new standard of care oral treatment for people with moderate-to-severe plaque psoriasis, given its profile in helping patients achieve clearer skin as demonstrated in the POETYK PSO clinical programme.
“People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”
The company further said, “In the POETYK PSO trials, at Week 16, the most common adverse reactions (≥1 per cent and higher than placebo) in patients on Sotyktu were upper respiratory infections (19.2 per cent), blood creatine phosphokinase increase (2.7 per cent), herpes simplex (2.0 percent), mouth ulcers (1.9 per cent), folliculitis (1.7 per cent) and acne (1.4 percent).
“In addition, 2.4 per cent of patients on Sotyktu, 3.8 per cent of patients on placebo, and 5.2 per cent of patients on Otezla experienced adverse reactions leading to discontinuation.”
The President and CEO of the National Psoriasis Foundation, Leah Howard said, “The FDA approval of a new oral treatment is exciting news for the psoriasis community. We welcome this new treatment option.”
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