Regulatory BMS Gains First FDA Approval For Drug That Treats...

BMS Gains First FDA Approval For Drug That Treats Psoriasis


Bristol-Myers Squibb has successfully gained approval from the U.S. Food and Drug Administration (FDA) as a treatment for medium-to-high levels of plaque psoriasis

Currently, Sotyktu (deucravacitinib) – an oral allosteric tyrosine kinase 2 (TYK2) inhibitor – remains the only approved inhibitor of its kind in the world. It is also the first breakthrough in oral treatment for medium-to-severe plaque psoriasis in nearly a decade.

BMS has said it plans to officially launch the new drug in a few weeks, as it aims to give tough competition to Otezla, Amgen’s $2.3 billion oral psoriasis drug. BMS believes that Sotyktu could potentially reach a valuation of $4 billion; previous head-to-head studies have shown it comes up triumphant at treating psoriasis against Amgen’s drug.

The FDA approval was based primarily on the POETYK PSO-1 and PSO-2 clinical trials,  in which nearly 1700 adults with medium-to-severe plaque psoriasis took part. According to the results, 59% and 54% of patients treated with deucravacitinib experienced 75% skin clearance at POETUK PSO-1 and PSO-2 respectively. On the other hand, only 35% and 40% of respective patients achieved the same result with Otezla.

Across both research studies, the most prevalent adverse effects impacting at least 1% of the patients on Sotyktu were respiratory diseases (19.2%), elevated levels of serum creatine phosphokinase (2.7%) and herpes simplex (2%).

“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 program,” stated April Armstrong the clinical investigator in the POETYK PSO-1 trial. “People living with moderate-to-severe plaque psoriasis face significant burdens, and Sotyktu is a welcome first-line systemic treatment option.”

Amgen acquired Otezla for $13.4 billion when Celgene merged with BMS in late 2019. The regulating authorities forced Celgene to offload Otezla before the merger, owing to fears that the presence of both Sotyktu and Otezla in the same company would provide it a strong foothold in the psoriasis pills market.

Psoriasis is a long-lasting skin condition that causes itchy blisters, typically on the elbows, knees and scalp. Plaque psoriasis is the most common type of the disease, characterized by dry and raised skin patches – also called plaques – filled with scales. These patches vary in color, depending on the patients’ skin tones, among other factors. Almost 25% of the total psoriasis cases are considered moderate-to-severe.

Samit Hirawat, the Chief Medical Officer at BMS, said that the FDA’s approval of Sotyktu represents a huge win for plaque psoriasis patients who don’t find the conventional treatments very effective. Not only is Sotyktu a true breakthrough for this condition, but it also holds significant potential in the treatment of other immune-mediated diseases.

A big relief for BMS is that the FDA considers deucravacitinib to have an unblemished safety profile, which will keep the drug away from regular inspection by the authorities. Moreover, the drug will not have any JAK-like warnings on its label, which will help bolster BMS’s efforts to extend its usage to other chronic diseases like lupus and psoriatic arthritis.

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