Bristol Myers Squibb Announces Positive CHMP Opinion for Deucravacitinib for Adults with Moderate to Severe Plaque Psoriasis
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Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
ShanghaiJanuary 29, 2023PR Newswire -- Bristol-Myers Squibb recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of deucravacitinib for the treatment of adult patients with moderate to severe plaque psoriasis. Deucravacitinib is an oral, once-daily treatment and the world's first selective allosteric inhibitor of tyrosine kinase 2 (TYK2), used to treat adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy. The CHMP’s opinion will now be submitted to the European Commission (EC) for review, which is responsible for the approval of medicines within the European Union (EU).
"Patients with moderate to severe psoriasis are still suffering from the symptoms of the disease. Many have not received treatment, have been inadequately treated, or are dissatisfied with current treatment options. There is a significant unmet need for more effective and better-tolerated oral therapies," said Smit Hirawat, M.D., Chief Medical Officer of Bristol-Myers Squibb. "For patients in the EU, this positive opinion from the CHMP represents an important step forward in addressing their unmet needs. We are also proud to advance this first-in-class therapy with durable efficacy further to patients in need. We look forward to deucravacitinib potentially becoming the standard in oral treatments."
The positive opinion adopted by the CHMP was based on results from the pivotal Phase III POETYK PSO-1 and POETYK PSO-2 studies, as well as two-year data from the POETYK PSO long-term extension trial. The POETYK PSO-1 and POETYK PSO-2 studies evaluated deucravacitinib (once daily) compared with placebo and Otezla in treating moderate to severe plaque psoriasis.®(Apremilast, twice daily, hereinafter referred to as "Apremilast"). The results showed that compared with placebo and Apremilast, deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden, and quality of life indicators. In addition, deucravacitinib was well tolerated, with a low discontinuation rate due to adverse events. The most common adverse reactions (≥1% of deucravacitinib patients) included upper respiratory tract infections, herpes simplex infections, oral ulcers, folliculitis, and acneiform rashes. The phase III results of POETYK PSO-1 and POETYK PSO-2 have been published in the Journal of the American Academy of Dermatology.
In September 2022, the U.S. Food and Drug Administration (FDA) approved deucravacitinib for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. In the same month, Japan's Ministry of Health, Labour and Welfare also approved deucravacitinib for the treatment of adult patients with plaque psoriasis, generalized pustular psoriasis, and erythrodermic psoriasis who have had an inadequate response to conventional therapies. Apart from the European Medicines Agency, the indication for deucravacitinib for the treatment of moderate to severe plaque psoriasis is also undergoing regulatory review by local health authorities in various regions worldwide.
Bristol-Myers Squibb sincerely thanks all the patients and researchers who participated in the POETYK PSO clinical study.
Deucravacitinib Not yet approved in China. This material is not for promotional use. For more medical professional information, please consult healthcare professionals.