Home Medizin EMA genehmigt Tx für Psoriasis und andere Autoimmunerkrankungen

EMA genehmigt Tx für Psoriasis und andere Autoimmunerkrankungen

von NFI Redaktion

In the February 2024 meeting, the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) granted market authorizations for Pyzchiva (Ustekinumab) for the treatment of plaque psoriasis, including plaque psoriasis in children; psoriatic arthritis; ulcerative colitis; and Crohn’s disease. Additionally, Apremilast Accord (Apremilast) was approved for the treatment of psoriatic arthritis, psoriasis, and Behçet’s disease.

During the authorization process, the EMA stated that the biosimilar Pyzchiva is very similar to the reference product Stelara (Ustekinumab), which was approved in the EU in 2009. The EMA added that data showed Pyzchiva to have comparable quality, safety, and efficacy to Stelara.

It was also noted that Apremilast Accord is a generic version of Otezla, which has been authorized in the EU since 2015. Studies demonstrated the satisfactory quality of Apremilast Accord and its bioequivalence to the reference product Otezla, according to the EMA.

Pyzchiva:

Ustekinumab, the active ingredient in Pyzchiva, is an immunosuppressive interleukin inhibitor. The monoclonal antibody exerts its clinical effect on psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease by interrupting the Th1 and Th17 cytokine pathways, as explained in the EMA’s summary statement.

Prevalence of psoriasis is estimated at 1.92% in Western Europe and 1.83% in Central Europe.

Ustekinumab was evaluated in three Phase 3 clinical trials for the treatment of moderate to severe plaque psoriasis – two placebo-controlled studies (PHOENIX 1 and PHOENIX 2) and a comparator-controlled study (ACCEPT). It proved effective for patients who had not received previous treatment, those who failed other immunosuppressive medications, those unresponsive to phototherapy, and those unable to tolerate or use other therapies.

Approximately 2.5 to 3 million people in Europe suffer from inflammatory bowel diseases, with an estimated prevalence of 0.64 per 100,000 individuals in the UK, 1.53 in Portugal, 2.26 in Germany, and 7.1 in France.

Studies UNITI-1 and UNITI-2 showed Ustekinumab to be effective and safe for treating moderate to severe Crohn’s disease. Patients with active Crohn’s disease who received intravenous Ustekinumab had a significantly higher response rate than those who received placebo. Subcutaneous Ustekinumab maintained remission in patients who clinically responded to induction therapy.

For the treatment of plaque psoriasis and psoriatic arthritis, the drug is typically injected subcutaneously every 4 weeks for the first two doses, then every 12 weeks thereafter. For Crohn’s disease and ulcerative colitis, it is initially injected intravenously and then subcutaneously every 8 weeks.

Pyzchiva: Complete Indications:

– Moderate to severe plaque psoriasis in adults who have not responded to other systemic therapies or cannot tolerate them.
– Moderate to severe plaque psoriasis in children and adolescents aged 6 years and older inadequately controlled by other systemic therapies or phototherapies.
– Active psoriatic arthritis, alone or in combination with methotrexate, in adult patients with inadequate response to previous non-biological DMARD therapy.
– Adult patients with moderate to severe active Crohn’s disease who have had an inadequate response to conventional therapy or a TNF-alpha antagonist, no longer respond to them, have an intolerance to them, or have medical contraindications for such therapies.
– Adult patients with moderate to severe active ulcerative colitis who have had an inadequate response to conventional therapy or a biologic, no longer respond to them, have an intolerance to them, or have medical contraindications for such therapies.

Apremilast Accord:

Apremilast Accord (Apremilast) is a phosphodiesterase-4 inhibitor used to treat psoriatic arthritis, psoriasis, and Behçet’s disease. This selective immunosuppressant inhibits phosphodiesterase 4 and increases intracellular cAMP levels, subsequently downregulating the inflammatory response.

The Phase 3 ADVANCE study showed that five times as many adults with mild to moderate plaque psoriasis achieved a sPGA response in week 16 compared to placebo. Improvements were also seen in the numerical rating scale for whole-body itching and global assessment by scalp physicians.

Behçet’s disease is rare in Europe, with a prevalence of 0.64 per 100,000 individuals in the UK, 1.2 in Sweden, 1.5 in Portugal, 3.7 in Italy, 5.6 in Spain, and 7.2 in France.

Apremilast was found to reduce the number of mouth ulcers in Behçet’s disease patients more effectively than placebo.

Orally, the dosage of Apremilast is gradually increased until the recommended dose of 30 mg twice daily is reached. The medication should be taken continuously to maintain improvement.

Apremilast Accord: Complete Indications:

– Active psoriatic arthritis, alone or in combination with DMARDs, in adults who have had an inadequate response to previous DMARD therapy or cannot tolerate them.
– Moderate to severe chronic plaque psoriasis in adults who have not responded to other systemic therapies or cannot tolerate them.
– Adult patients with mouth ulcers associated with Behçet’s disease eligible for systemic therapy.

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