Marketing authorisation in Great Britain has been granted for deucravacitinib by the MHRA for use in the treatment of moderate to severe plaque psoriasis in adults.
Earlier this year, deucravacitinib (Sotyktu, Bristol Myers Squibb), was recommended by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. In the US, the FDA approved the drug in September 2022.
Now, the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for the drug in Great Britain.
The Psoriasis Association said that an estimated between 2-3% of the UK population were affected with the condition – this equated to up to 1.8 million people, the charity highlighted. It is believed that 90% of people are affected by plaque psoriasis - the most common form of the condition, with around 20% affected by moderate to severe disease.
Professor Richard Warren, Manchester University, and Northern Care Alliance, commented: "Despite affecting a significant percentage of the population and for many, having a serious impact on their physical and mental health, patients with chronic conditions such as psoriasis have few effective oral options to manage their condition."
Pivotal Data Lead to Authorisation
Deucravacitinib is a selective allosteric tyrosine kinase 2 (TYK2) inhibitor – a member of the janus kinase (JAK) family – and works by blocking the action of the abnormal protein that signals cells to multiply. The 'first-in-class' treatment is taken orally once a day.
The pharmaceutical company behind the drug explained that the marketing authorisation was based on "pivotal" data from the Phase 3 POETYK PSO-1 and POETYK PSO-2 clinical trials.
These demonstrated that deucravacitinib had superior efficacy and ability to improve the skin condition and symptoms in adult patients with moderate to severe forms of the condition compared to a placebo and to the PDE-4 inhibitor apremilast.
At 16 weeks it achieved significantly higher response rates for Psoriasis Area and Severity Index (PASI 75) – 58.4% versus 12.7% versus 35.1%, respectively – and for static Physician's Global Assessment score of 0 or 1 (sPGA 0/1) – 53.6% versus 7.2% versus 32.1%, respectively – reported the authors of the studies. Efficacy improved beyond week 16 and was maintained through week 52, they said.
Deucravacitinib was well tolerated in moderate to severe plaque psoriasis, with the most commonly reported adverse reaction being upper respiratory infections (18.9%), most frequently nasopharyngitis, explained a company spokesperson.
Professor Warren applauded the announcement, and emphasised that it would potentially offer eligible patients a new treatment option to help manage the significant symptoms associated with the condition.
Asked to comment for Medscape UK , Laura Stevenson, deputy chief executive at the Psoriasis Association emphasised how having psoriasis can have a significant life impact.
It is "hugely important" for those with psoriasis to have access to a "variety of treatments", stressed Ms Stevenson, who believed that the approval of deucravacitinib would make a "real difference" for people with psoriasis.
NICE guidance on the use of deucravacitinib for moderate to severe plaque psoriasis is in progress, with the publication date still to be confirmed.
