Ilumya gets FDA approval for psoriasis

[Fred]

Update to this thread:

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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. 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. Tildrakizumab constitutes an important step forward in the treatment of moderate-to-severe chronic plaque psoriasis.

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. The low frequency of injections, only 4 doses per year during maintenance, may also encourage adherence.

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.

Source: almirall.com