In its February 2024 meeting, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use has granted marketing authorizations for Pyzchiva (ustekinumab) for the treatment of plaque psoriasis, including pediatric plaque psoriasis; psoriatic arthritis; ulcerative colitis; and Crohn’s disease. It also approved Apremilast Accord (apremilast) for the treatment of psoriatic arthritis, psoriasis, and Behçet disease.
In granting the authorizations, the EMA explained that the biosimilar Pyzchiva was highly similar to the reference product Stelara (ustekinumab), which was authorized in the EU in 2009. The EMA added that data showed that Pyzchiva has comparable quality, safety, and efficacy to Stelera.
It also highlighted that Apremilast Accord is a generic of Otezla, which has been authorized in the EU since 2015. Studies had demonstrated the satisfactory quality of Apremilast Accord and its bioequivalence to the reference product Otezla, the EMA said.
Pyzchiva
Ustekinumab is the active substance of Pyzchiva, an immunosuppressant interleukin inhibitor. The monoclonal antibody may exert its clinical effects in psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease through interruption of the Th1 and Th17 cytokine pathways, the EMA said in its summary of opinion.
The prevalence of psoriasis is estimated to be 1.92% in Western Europe and 1.83% in Central Europe.
Ustekinumab had been evaluated for the treatment of moderate to severe plaque psoriasis in three phase 3 clinical trials, two placebo-controlled studies (PHOENIX 1 and PHOENIX 2), and one comparator-controlled study (ACCEPT). It was found to be effective in patients who had not received previous treatment, those in whom other immunosuppressive medications had failed, those who were unresponsive to phototherapy, and those who were unable to use or tolerate other therapies.
About 2.5-3 million people in Europe are affected by inflammatory bowel disease, with an estimated prevalence of 0.64 per 100,000 persons in the UK, 1.53 in Portugal, 2.26 in Germany, and 7.1 in France.
The UNITI-1 and UNITI-2 trials demonstrated that ustekinumab was effective and safe when used to treat moderate to severe Crohn’s disease. Among patients with moderately to severely active Crohn’s disease, those receiving intravenous ustekinumab had a significantly higher rate of response than did those receiving placebo. Subcutaneous ustekinumab maintained remission in patients who had a clinical response to induction therapy.
For the treatment of plaque psoriasis and psoriatic arthritis, the drug is usually injected subcutaneously every 4 weeks for the first two doses and then every 12 weeks for as long as treatment continues. For the treatment of Crohn’s disease and ulcerative colitis, it is usually injected intravenously for the first dose and then given subcutaneously every 8 weeks for as long as treatment continues.
Pyzchiva: Full Indications
Moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate, or psoralen and ultraviolet A (PUVA).Moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.Active psoriatic arthritis — alone or in combination with methotrexate — in adult patients when the response to previous non-biological disease-modifying anti- rheumatic drug (DMARD) therapy has been inadequate.Adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNF alpha antagonist or have medical contraindications to such therapies.Adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.
Apremilast Accord
Apremilast Accord (apremilast) is a phosphodiesterase 4 inhibitor for the treatment of psoriatic arthritis, psoriasis, and Behçet disease. The selective immunosuppressant inhibits the action of phosphodiesterase 4, thereby increasing intracellular cAMP levels, which in turn downregulates the inflammatory response.
The phase 3 ADVANCE trial found that that five times as many adults with mild-to-moderate plaque psoriasis achieved a Static Physician’s Global Assessment (sPGA) response — defined as an sPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline — at week 16 compared with placebo. In addition, improvements were seen in Whole Body Itch Numeric Rating Scale response and Scalp Physicians Global Assessment.
Behçet disease is uncommon in Europe, with prevalence estimates of 0.64 per 100,000 persons in the UK, 1.2 in Sweden, 1.5 in Portugal, 3.7 in Italy, 5.6 in Spain, and 7.2 in France.
A trial of apremilast for oral ulcers in Behçet disease had found that treatment with the drug resulted in a greater reduction in the number of oral ulcers than placebo.
Taken orally, the dosage is gradually increased until the recommended dose of 30 mg twice daily is reached. The drug is taken continuously to maintain improvement.
Apremilast Accord: Full Indications
Active psoriatic arthritis — alone or in combination with DMARDs — in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapy.Moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate, or PUVA.Adult patients with oral ulcers associated with Behçet disease who are candidates for systemic therapy.
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