Health Canada's approval of Taltz™ (ixekizumab) Brings Targeted Therapy to Canadians Living with Moderate-to-Severe Plaque Psoriasis

TORONTO, June 21, 2016 /CNW/ - Eli Lilly Canada announced today that Health Canada has granted approval for Taltz^™ (ixekizumab) for the treatment of moderate-to-severe plaque psoriasis in Canadian adults who are candidates for systemic therapy or phototherapy.¹

More than 500,000 Canadians are living with psoriasis.² Plaque psoriasis, the most common form of the disease,³ presents as thickened red plaques on the skin that are often covered with silvery, flaking scales. These plaques are usually painful or itchy. They can be physically incapacitating and socially isolating.²

Experts do not know why certain people develop psoriasis.⁴ The disease is believed to be related to a malfunctioning of the immune system that triggers inflammation.⁴

"There is a lot of misinformation about the disease – people think it's contagious through touch and would often stare or not want to be close to you," explained Brenda Spinozzi, who lives with the disease. "Psoriasis is a painful, disfiguring skin disease that causes shame. But when you find the treatment that works for you, it can be life-changing."

Health Canada's approval of Taltz is based on data from three double-blind multicentre Phase III studies – UNCOVER-1, UNCOVER-2, and UNCOVER-3 – which evaluated more than 3,800 patients (over 650 Canadians⁵) with moderate-to-severe plaque psoriasis¹ from 21 countries⁶, involving more than 35 Canadian physicians.⁵ This number includes patients who began the trials on Taltz, placebo, or active comparator (etanercept).⁷ 

Taltz is specifically designed to target the cytokine interleukin 17A (IL-17A),¹ a protein that plays a role in driving the underlying inflammation in psoriasis.⁸

"Taltz belongs to a newer generation of medications that works by going to the source of inflammation and blocking a very specific portion of the immune system's response," said Dr. Kim Papp, principal investigator for UNCOVER-2, who is based in Waterloo, Ontario. "Patients achieved clearer skin, which was maintained with ongoing treatment.  From my personal clinical experience, I'm encouraged by these results."

"Psoriasis patients require lifelong medical care, and the physical and mental burden of the condition is similar to that associated with other serious chronic illnesses" said Dr. Doron Sagman, Vice President, Research & Development at Lilly Canada. "We are pleased to provide physicians a promising treatment option for patients struggling to manage this often debilitating condition." 

The UNCOVER series of studies evaluated the safety and efficacy of Taltz (80 mg every two or four weeks, following a 160 mg starting dose) compared to placebo after 12 weeks.⁷ UNCOVER-2 and UNCOVER-3 included an active comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.⁷

UNCOVER-1 and UNCOVER-2 also evaluated the maintenance and durability of response with Taltz through 60 weeks.⁶ The research showed high levels of efficacy sustained through week 60.⁶

The recommended dose for Taltz is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) at Weeks 2, 4, 6, 8, 10 and 12, then 80 mg (one injection) every four weeks.¹ Taltz is administered by subcutaneous injection, either via a prefilled auto-injector or a prefilled syringe.¹

Lilly received a Notice of Compliance for Taltz from Health Canada on May 25, 2016. ⁹

Notes to Editors:

About Taltz^™ (ixekizumab)
Taltz^™ (ixekizumab) is a humanized IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor.¹ IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses.¹⁰ Taltz inhibits the release of pro-inflammatory cytokines and chemokines.¹¹ 

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 psoriasis¹ from 21 countries⁶, including Canada. ¹² All three studies evaluated the safety and efficacy of different dosing regimens of Taltz (80 mg every two or four weeks, following a 160 mg starting dose) compared to placebo after 12 weeks.⁷ UNCOVER-2 and UNCOVER-3 included an active comparator arm in which patients received etanercept (50 mg twice a week) for 12 weeks.⁷ UNCOVER-1 and UNCOVER-2 also evaluated the maintenance and durability of response with Taltz through 60 weeks.⁶ The most frequently reported adverse drug reactions in the clinical trials were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).¹

About Moderate-to-Severe Plaque Psoriasis
Psoriasis is a chronic immune-mediated disease that affects the skin.¹³ There are 125 million people worldwide living with the disease¹³ including more than 500,000 Canadians.² Psoriasis occurs when an overactive immune system sends out faulty signals that speed up the growth cycle of skin cells.¹³ Plaque psoriasis is the most common form of the condition³ and appears as raised, red patches of skin covered with a silvery, white buildup of dead skin cells, which are often painful or itchy and can crack and bleed.² Psoriasis can appear on any part of the body, but most commonly occurs on the scalp, knees, elbows and torso.13 In addition to physical symptoms, psoriasis can have a significant impact on an individual's quality of life and has been associated with an increased risk of other serious health conditions, including diabetes, heart disease,¹³ and some cancers.¹⁴

The exact cause of psoriasis is unknown, though genetics and environmental factors play a role in the development of the disease.¹³

Clinicians and researchers have two commonly used tools to measure the extent and severity of psoriasis:²

1.  The Psoriasis Area Severity Index (PASI):  assesses the 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.²

2.  The static Physician's Global Assessment (sPGA): assesses the severity of a patient's psoriasis lesions overall at a specific point in time.²

Both assessment tools (PASI and sPGA) are in line with Canadian guidelines to assess the effectiveness of treatments for psoriasis.²

About Eli Lilly Canada Inc.
Eli Lilly and Company 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 Colonel Eli Lilly, who was committed to creating high quality medicines that meet people's needs, and today we remain true to that mission in all our work. Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and contribute to our communities through philanthropy and volunteerism.

Eli Lilly Canada was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially-available insulin. Lilly Canada now employs 598 people across the country, working in the areas of oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Lilly Canada, please visit us at www.lilly.ca.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Taltz (ixekizumab) 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.

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¹ Taltz™ (ixekizumab) Product Monograph. Toronto, ON: Eli Lilly Canada Inc., 2016.

²  Canadian Guidelines for the Management of Plaque Psoriasis, 1^st Edition, June 2009 http://www.dermatology.ca/wp-content/uploads/2012/01/cdnpsoriasisguidelines.pdf. Accessed June 10, 2016.

³ National Psoriasis Foundation, About Psoriasis https://www.psoriasis.org/about-psoriasis/types/plaque. Accessed June 10, 2016.

⁴ Canadian Association of Dermatology, What is Psoriasis? http://www.dermatology.ca/skin-hair-nails/skin/psoriasis/#!/skin-hair-nails/skin/psoriasis/what-is-psoriasis/. Accessed June 10, 2016.

⁵  Summary of Clinical Efficacy Appendix Table APP 2.7.3.6.2

⁶ Gordon, Kenneth B., M.D. et al. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis, New England Journal of Medicine, June 8, 2016 │DOI: 10.1056/NEJMoa1512711, http://www.nejm.org/doi/full/10.1056/NEJMoa1512711#t=articleTop. Accessed June 9, 2016.

⁷ 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.

⁸ 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.

⁹  Health Canada Notice of Compliance Information http://webprod5.hc-sc.gc.ca/noc-ac/info.do?no=18129&lang=eng. Accessed June 7, 2016.

¹⁰ National Psoriasis Foundation, Moderate to severe psoriasis and psoriatic arthritis: biologic drugs https://www.psoriasis.org/about-psoriasis/treatments/biologics. Accessed June 7, 2016.

¹¹ Lønnberg AS, Zachariae C, Skov L. Targeting of interleukin-17 in the treatment of psoriasis. Clinical, Cosmetic and Investigational Dermatology. 2014;7:251-259.doi:10.2147/CCID.S67534.

¹²  Supplement to: Griffiths CEM, Reich K, Lebwohl M, et al, for the UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet 2015; published online June 10. http://dx.doi.org/10.1016/S0140-6736(15)60125-8..

¹³ National Psoriasis Foundation, Psoriasis Media Kit https://www.psoriasis.org/sites/default/files/for-media/MediaKit.pdf. Accessed June 7, 2016.

¹⁴ Zelma C, et al. The Risk of Cancer in Patients With Psoriasis: A Population-Based Cohort Study in the Health Improvement Network. JAMA Dermatol. 2016;152(3):282-290. http://archderm.jamanetwork.com/article.aspx?articleID=2475006. Accessed June 7, 2016.

SOURCE Eli Lilly Canada Inc.

Jane Lee Cheung, [email protected], [phone] (Eli Lilly Canada)