- Final NICE approval is expected in April 2019
- From this date, dermatologists in the UK will have an additional biologic treatment option and suitable patients can be considered for treatment with ILUMETRI® (tildrakizumab)
- Tildrakizumab is a high-affinity humanized monoclonal antibody that inhibits the p19 subunit of IL-231, that has demonstrated lasting efficacy and safety through 3 years according to the positive results of a pooled analysis2 of two phase III clinical trials
- Tildrakizumab was approved by the European Commission in September 2018, is already available in Germany and is due to be marketed in all EU Member states
Almirall, S.A. (ALM), announced today that the NICE (National Institute for Health and Care Excellence, in the UK) has provisionally recommended approval of ILUMETRI® (tildrakizumab), a humanized, high-affinity IL-23p19 monoclonal antibody, for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy.1 Following a single health technology assessment submission to NICE in August 2018 and the subsequent questions for clarification and appraisal committee meetings, NICE completed their assessment of tildrakizumab and has now issued a Final Appraisal Determination (FAD) provisionally recommending tildrakizumab as a cost effective treatment option for the NHS for the patients specified in the FAD. Final NICE approval is expected in April 2019.
As remarked by Jacob Anker Rasmussen, Almirall’s General Manager UK & Nordics, “the provisional recommendation by the NICE appraisal committee, who agreed that tildrakizumab is a cost effective option, is excellent news for both dermatologists and patients. It means that dermatologists in the UK now have an additional biologic treatment option and suitable patients can now be considered for tildrakizumab“.
Tildrakizumab is a high affinity, humanised, IgG1 K antibody targeting interleukin IL 23 p19 that represents an evolving treatment strategy in chronic plaque psoriasis.3 Tildrakizumab constitutes an important step forward in the treatment of moderate-to-severe chronic plaque psoriasis.3
Tildrakizumab is administered by subcutaneous injection. Its convenient dosing regimen, every 3 months during maintenance, could offer greater convenience and quality of life for patients, potentially achieving an improved treatment satisfaction.4 The low frequency of injections, only 4 doses per year during maintenance, may also encourage adherence.4
Almirall in-licensed tildrakizumab from Sun Pharmaceutical Industries Ltd. (Sun Pharma) in July 2016. The agreement is for development and commercialization of ILUMETRI® (tildrakizumab) in Europe. It was approved by the European Commission in September 2018, is already available in Germany and is due to be marketed in all EU Member states.
Approval based on reSURFACE 1 and reSURFACE 2 phase III trials positive results
Its approval in Europe is based on reSURFACE 1 and 23 positive results, with the dose of 100mg. Both pivotal phase III clinical trials, which included over 1,800 patients from more than 200 clinical sites worldwide, showed that Tildrakizumab offers clinically meaningful benefits over time, which is promising news for patients and clinicians.3
According to both studies’ data, an average of 62% of patients achieved 75% of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 and an average of 77% at week 28 after only three doses. Moreover, an average of 54% of patients achieved PASI 90 and an average of 29% reached PASI 100 at week 28.4
The results of a pooled analysis through 3 years2 from reSURFACE 1 and reSURFACE 2 phase III trials3show the consistent maintenance of efficacy and safety over three years of tildrakizumab in patients with moderate-to-severe plaque psoriasis who were responders at week 28. According to the data, PASI 75 responses were maintained with continued treatment with tildrakizumab in 9 out of 10 patients up to week 148.3,4 More than 50% of patients reported that psoriasis no longer affected their lives after only 3 doses.1,3,4 Tildrakizumab was well-tolerated with very low drug-related serious adverse events and discontinuation rates.1,2
Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.8 million adults in Europe and approximately 125 million people worldwide.5 It is a non-contagious disorder that accelerates the growth cycle of skin cells and results in thick scaly areas of skin. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed. Despite different treatment options existing, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease.
Almirall is a leading skin-health focused global pharmaceutical company that partners with healthcare professionals, applying Science to provide medical solutions to patients & future generations. Our efforts are focused on fighting against skin health diseases and helping people feel and look their best. We support healthcare professionals in its continuous improvement, bringing our innovative solutions where they are needed.
The company, founded 75 years ago and with headquarters in Barcelona, is listed on the Spanish Stock Exchange (ticker: ALM). Almirall has become a key element of value creation to society according to its commitment to major shareholders and its decision to help others, to understand their challenges and to use Science to provide them with solutions for real life. Total revenues in 2018 were 811 million euros. More than 1,830 employees are devoted to Science.
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