Ilumya gets FDA approval for psoriasis

[Fred]

Ilumya (tildrakizumab-asmn) has been given U.S. Food and Drug Administration (FDA) approval for the treatment of adults with moderate-to severe plaque psoriasis.

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Sun Pharma today announced that the U.S. Food and Drug Administration (FDA) has approved ILUMYA (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

ILUMYA selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of pro innflammatory cytokines and chemokines. ILUMYA is administered at a dose of 100 mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4. ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.

The FDA approval of ILUMYA for the treatment of adults with moderate-to-severe plaque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development program. In the two multicenter, randomized, double-blind, placebo-controlled trials (reSURFACE 1 and reSURFACE 2), 926 adult patients were treated with ILUMYA (N=616) or placebo (N=310). Both Phase-3 studies met the primary efficacy endpoints, demonstrating significant clinical improvement with ILUMYA 100 mg compared to placebo when measured by at least 75 percent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) and Physician’s Global Assessment (PGA) score of “clear” or “minimal” at week 12 after two doses.

Of the patients in the reSURFACE 1 study 74 percent (229 patients) achieved 75 percent skin clearance at week 28 after three doses, and 84 percent of patients who continued receiving ILUMYA 100 mg maintained PASI 75 at week 64 compared to 22 percent of patients who were re-randomized to placebo. In addition, 69 percent of the patients receiving ILUMYA 100 mg who had a PGA score of “clear” or “minimal” at week 28 maintained this response at week 64 compared to 14 percent of patients who were re-randomized to placebo.

Source: sunpharma.com

[Fred]

Update to this thread:

Given a different name which is usual for the EU.

Sun Pharma today announced that Almirall has received the European Commission (EC) approval for ILUMETRI (tildrakizumab) for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy. As indicated by Almirall, roll out of ILUMETRI in Europe will start in the next few weeks.

[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

[Kat]

I like that it's only 4 injections per year! (That was my favorite part of Stelara)

No info on how well it works for psoriatic arthritis?

[Fred]

I like that it's only 4 injections per year!   (That was my favorite part of Stelara)

No info on how well it works for psoriatic arthritis?

Early days yet Kat. That usually comes after they have people settled on it for psoriasis.