Bristol Myers Squibb’s Sotyktu recommended by NICE for plaque psoriasis

2023-06-28

临床3期上市批准临床结果

Bristol Myers Squibb’s Sotyktu recommended by NICE for plaque psoriasis

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来源: PMLiVE

Bristol Myers Squibb's (BMS) Sotyktu (deucravacitinib) has been recommended by the National Institute for Health and Care Excellence (NICE) for use on the NHS in England as a treatment option for certain adults with moderate-to-severe plaque psoriasis.

The new guidance specifically applies to patients with a Psoriasis Area and Severity Index score of ten or more, a Dermatology Life Quality Index score of over ten, and who have not responded to or been able to receive other systemic treatments, including ciclosporin, methotrexate and phototherapy.

It is estimated that up to 1.8 million people in the UK are affected by some form of psoriasis, a life-long inflammatory condition that typically affects the skin, nails and joints.

Up to 90% of patients have plaque psoriasis, characterised by distinct round or oval plaques typically covered by silvery-white scales.

Despite the availability of effective systemic therapies, BMS has reported that many patients with moderate-to-severe psoriasis remain under-treated, untreated or dissatisfied with current treatment options.

The decision from NICE follows the Medicines and Healthcare products Regulatory Agency's (MHRA) approval of Sotyktu in May this year for moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy.

This was supported by positive results from two phase 3 trials, in which once-daily Sotyktu was associated with superior improvements in skin clearance, symptom burden and quality of life measures compared to both placebo and twice-daily Otezla (apremilast).

“Today’s announcement marks another step forward for people with psoriasis,” said Chris Griffiths, emeritus professor at the University of Manchester.

He continued: "This complex condition can affect each person differently, therefore, it is my hope that access to a greater variety of treatments, such as [Sotyktu], will enable eligible patients to have more choice, with therapies that may suit their daily needs and lifestyle.”

Sotyktu is already approved in major markets, including the US and Japan. The therapy was also approved in the EU earlier this year for moderate-to-severe plaque psoriasis.

The European Commission’s decision, which followed a recommendation from the Committee for Medicinal Products for Human Use, made Sotyktu the first oral, selective, allosteric tyrosine kinase 2 inhibitor tyrosine kinase 2 inhibitor in the EU for the treatment of any disease.

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