Almirall, S.A. (ALM) announced today that it has signed an agreement with the French Authorities to make the biologic treatment ILUMETRI® (tildrakizumab), a high-affinity IL-23p19 monoclonal antibody, available in France for the treatment of adult patients with severe plaque psoriasis who are candidates for biological systemic therapy.
The agreement has been signed after the Commission of Transparency of the Haute Autorité de Santé (HAS), the French National Health Authority, provided a favourable opinion for the reimbursement in France of ILUMETRI® (tildrakizumab) on June 3rd and considered the actual benefit (Service Médical Rendu or SMR) as “important”. The prevalence of chronic plaque psoriasis among the French population is around 5,6%.
Following the publication of the agreement in the French Official Journal, Ilumetri® (tildrakizumab) will be included in the list of reimbursable medicines by the social insurance for the treatment of adults with severe chronic plaque psoriasis. Its use is reserved, like the rest of systemic biological treatments approved in France, for those patients who have failed (defined by insufficient response, contraindication or intolerance) at least two treatments among non-biological systemic treatments and phototherapy, as well as having a significant impact in the skin and/or a significant psychosocial impact.
“Today’s announcement represents great news for those patients with severe psoriasis across France who can count on a safe and convenient biological treatment for their condition. Ilumetri® provides sustained high efficacy and safety, and improves patients’ quality of life” said Alfredo Barón, Chief Commercial Officer of Almirall. “We are glad we could collaborate with French authorities to find an agreement to provide sustainable access to an additional biologic treatment option for patients suffering from this skin disease through a national reimbursement agreement,” he added.
The commercialization of Ilumetri® in France represents a key milestone of Almirall’s strategy to strengthen its leadership in medical dermatology through strong investments in R&D to bring ground-breaking solutions to patients suffering from dermatological conditions.
Ilumetri® (tildrakizumab) is the first biologic marketed by Almirall and constitutes an important step forward in the treatment of moderate-to-severe chronic plaque psoriasis. Since its approval by the European Commission in November of 2018, the product has been, offering a decisive benefit to patients as it has the longest efficacy and safety data among the IL23p19´s Ilumetri is reimbursed in 10 countries around Europe, including recent agreements in Belgium and Italy.
Tildrakizumab is administered by subcutaneous injection. Its convenient dosing regimen, with lower frequency of injections,only 4 injections per year during maintenance, offers convenience and quality of life for patients, potentially achieving an improved treatment satisfaction and improving adherence to treatment. The favourable opinion of the Commission was based on the analysis of clinical trials reSURFACE 1 and 2.
