BASINGSTOKE, April 26, 2016 – Eli Lilly and Company (NYSE: LLY) announced today that the European Commission has granted marketing authorisation for ixekizumab (Taltz) for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union (EU) who are candidates for systemic therapy.i Ixekizumab is specifically designed to target the cytokine interleukin IL-17A, a protein that plays a role in driving underlying inflammation in psoriasis.ii
“Psoriasis can have a profound, detrimental impact on a person’s quality of life,” said Professor Christopher Griffiths, Foundation Professor of Dermatology, University of Manchester. “As such, the authorisation of ixekizumab will offer a new biological treatment option for patients with moderate-to-severe plaque psoriasis.”
“Psoriasis is a serious, chronic disease, associated with significant comorbidities including heart disease. There is currently no cure for psoriasis,” said Andrew Hotchkiss, president of Lilly’s European and Canadian operations. “Lilly is excited to make ixekizumab available in the European Union for physicians looking to provide a new treatment option for patients with moderate-to-severe plaque psoriasis.”
The marketing authorisation of ixekizumab is based on data from seven clinical trials, including three pivotal double-blinded multicentre Phase III studies – UNCOVER-1, UNCOVER-2 and UNCOVER-3 – which evaluated more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries.iii This number includes patients who began the trial on ixekizumab or placebo, or active comparator (etanercept).iiiThe very common (≥1/10 patients)adverse events in clinical trials were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).iii
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Notes to Editors:
About Ixekizumab (Taltz)
Ixekizumab (Taltz) is a humanised IgG4 monoclonal antibody that selectively binds with high affinity to the interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.iii IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses, and elevated levels of IL-17A have been implicated in the pathogenesis of a variety of autoimmune diseases such as psoriasis.iii Neutralisation of IL-17A by ixekizumab inhibits these pro-inflammatory actions.iii
Ixekizumab is administered by subcutaneous injection, either via auto-injector or prefilled syringe.iii
In UNCOVER-1 the results show that when treated every two weeks with ixekizumab for 12 weeks following a starting dose, approximately 9 of 10 patients achieved a PASI 75 score.iiiIn both UNCOVER-2 and UNCOVER-3 etanercept was used as an active comparator. The results show that approximately 9 of 10 patients treated with ixekizumab every two weeks achieved a PASI 75 score at week 12, and approximately 8 of 10 patients achieved clear or almost clear skin as defined by sPGA 0 or 1 respectively.iii,[iv]
Numerous secondary end points were also collected from the UNCOVER series of trials, including higher levels of clearance, (PASI 90, 100 and sPGA 0). The impact of psoriasis on patient's lives was assessed using patient reported outcome measures, including the DLQI. Across UNCOVER-1 and UNCOVER 2&3, 35.3 percent and 39 percent of patients, respectively achieved PASI 100 (clear skin) after 12 weeks of treatment with ixekizumab.iii
The approved dosing regimen for ixekizumab is a 160-mg starting dose by subcutaneous injection (two 80-mg injections) at Week 0, followed by 80 mg (one injection) every two weeks through 12 weeks, then maintenance dosing of 80 mg (one injection) every four weeks.iii
Lilly received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on February 25, 2016.v
The very common (≥1/10 patients) adverse events in clinical trials were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).iii
About the UNCOVER Studies
The UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies are double-blind, multicentre, Phase III studies evaluating more than 3,800 patients with moderate-to-severe plaque psoriasis from 21 countries.iii
All three studies evaluated the safety and efficacy of different dosing regimens of ixekizumab (80 mg every two or four weeks, following a 160-mg starting dose) compared to placebo after 12 weeks.iii
· UNCOVER-2 and UNCOVER-3 included an additional comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.iv
· UNCOVER-1, UNCOVER-2 and UNCOVER-3 also evaluated response rates with ixekizumab during the maintenance period through 60 weeks, with UNCOVER-1 and UNCOVER-2 employing a randomized withdrawal design.iii,iv
· In these studies, the co-primary efficacy endpoints at 12 weeks were Psoriasis Area Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0 or 1.iiiPASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions (each graded on a zero to four scale), weighted by the body surface area of involved skin, while the sPGA is the physician’s assessment of severity of a patient’s psoriasis lesions overall at a specific point in time.vi Both assessment tools (PASI and sPGA) are in line with CHMP guidelines to assess the effectiveness of treatments for psoriasis.vii
About Moderate-to-Severe Plaque Psoriasis
Psoriasis is a chronic, immune disease that affects the skin.viii It occurs when the immune system sends out faulty signals that speed up the growth cycle of skin cells.ix Psoriasis affects up to 1.8 million people in the UK,ix approximately 20 percent of whom have moderate-to-severe plaque psoriasis.viiiPsoriasis can occur on any part of the body and is associated with other serious health conditions, such as diabetes and heart disease.x The most common form of psoriasis, plaque psoriasis, appears as raised, red patches covered with a silvery white buildup of dead skin cells.viii
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at: www.lilly.co.uk
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about ixekizumab (Taltz) as a treatment for moderate-to-severe plaque psoriasis, and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialisation. Among other things, there can be no guarantee that Taltz will receive additional regulatory approvals or be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.
Job bag: UKIXE00003
Date of prep: April 2016
[i] Lilly Data on File
[ii] Krueger JG, Fretzin S, Suárez-Fariñas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012;130(1):145-54.
[iii] Taltz® Summary of Product Characteristics. Eli Lilly. April 2016.
[iv] Griffiths C, Reich K, Lebwohl M, et al. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. The Lancet. 2015;386(9993):541-551.
[v] CHMP summary of positive opinion for Taltz
[vi] Feldman SR, Krueger GG. Psoriasis assessment tools in clinical trials. Ann Rheum Dis. 2005;64:ii65- ii68.
[vii] EMA. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf. Accessed April 21, 2016.
[viii] Menter A, Gottlieb A, Feldman SR, et al. (2008) Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5):826-50
[ix] The Psoriasis Association. About Psoriasis. https://www.psoriasis-association.org.uk/. Accessed April 14, 2016
[x] Kimball AB, et al. National Psoriasis Foundation clinical consensus on psoriasis comorbidities and recommendations for screening. J Am Acad Dermatol. 2008;58:1031–1042.
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