Lilly receives EU Marketing Authorisation for Taltz (ixekizumab) for the Treatment of Active Psoriatic Arthritis

BASINGSTOKE, England--(BUSINESS WIRE)--Eli Lilly and Company announced today that the European Commission has granted marketing authorisation (MA) for Taltz® (ixekizumab), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drug (DMARD) therapies.i,ii,iii

“Psoriatic arthritis is a common inflammatory arthritis that causes serious joint pain and swelling. This makes even simple daily activities hard to do. New effective treatments which make lives better are very welcome” said Professor Bruce Kirkham, Consultant Rheumatologist, Guy’s and St Thomas’ NHS Foundation Trust, London.

“PsA affects up to 30% of people who are already living with psoriasis,iv said Arash Tahbaz, Senior Medical Director, Eli Lilly and Company UK and Northern Europe. “Symptoms often begin around a decade after the onset of psoriasis, and can severely impact people’s lives and ability to work.iv We are proud to be able to offer a new treatment option that addresses both the joint and skin symptoms of PsA.”

Ixekizumab is a monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine and inhibits its interaction with the IL-17 receptor. This is the second approved indication for ixekizumab in the EU. Ixekizumab was authorized for the treatment of adult patients with moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy in Europe in April 2016.v

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Notes to Editors

About Taltz (ixekizumab)

Ixekizumab is an IgG4 monoclonal antibody that selectively binds with interleukin 17A (IL-17A) cytokine (<3pM) and inhibits its interaction with the IL-17 receptor. IL-17A is a naturally occurring cytokine that is involved in normal inflammatory and immune responses. Ixekizumab inhibits the release of pro-inflammatory cytokines and chemokines.

The European Commission Marketing Authorisation for ixekizumab in PsA was based on findings from a Phase 3 clinical trial program. The efficacy and safety of ixekizumab was determined from findings from two randomized, double-blind, placebo-controlled Phase 3 studies– SPIRIT-P1 and SPIRIT-P2 – which included 780 adult patients with active PsA.

  • SPIRIT-P1 evaluated the safety and efficacy of ixekizumab compared to placebo in patients with active PsA who had never been treated with a biologic disease-modifying antirheumatic drug.
  • SPIRIT-P2 evaluated the safety and efficacy of ixekizumab compared to placebo in tumor necrosis factor inhibitor (TNFi)-experienced patients with active PsA who failed one or two TNF inhibitors.
  • Across both studies, patients were required to have a diagnosis of active PsA for at least six months and at least three tender and three swollen joints. Non-responder imputation (NRI) methods were used. Inadequate responders (defined by blinded tender and swollen joint count criteria) at Week 16 received rescue therapy and were analyzed as non-responders.
  • Results from both studies demonstrated that patients treated with ixekizumab achieved significant improvement in joint symptoms and skin symptoms compared with placebo. In both studies, the primary efficacy endpoint was the proportion of biologic-naïve and TNFi-experienced patients at 24 weeks achieving ACR20 response, which represents a 20-percent reduction in a composite measure of disease activity as defined by the American College of Rheumatology (ACR). Additionally, both studies evaluated improvement in psoriasis plaques at 12 weeks, as measured by a 75-percent improvement in the Psoriasis Area Severity Index (PASI). PASI measures the extent and severity of psoriasis by assessing average redness, thickness and scaliness of skin lesions, weighted by the body surface area of involved skin. Treatment-emergent adverse events (TEAE) in both studies were more frequent with ixekizumab than placebo. The majority of TEAE were mild or moderate in severity; < 5% were rated severe.

About Psoriatic Arthritis

Psoriatic arthritis (PsA) is a chronic, progressive form of inflammatory arthritis that can cause swelling, stiffness and pain in and around the joints and impaired physical function. iv It occurs when an overactive immune system sends out faulty signals that cause inflammation, leading to swollen and painful joints and tendons.iv Psoriatic arthritis can affect peripheral joints in the arms and legs (elbows, wrists, hands and feet). iv If left untreated, PsA can cause permanent joint damage.iii Up to 30 percent of people with psoriasis also develop PsA.iv

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

References

i Lilly Data on File Ref. BSD-IX-GB-0001

ii European Medicines Agency (EMA) http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion/human/003943/WC500240383.pdf (accessed January 2018)

iii Lilly Data on File Ref. 36677

iv Ritchlin C, et. al. Psoriatic Arthritis. New England Journal of Medicine. 2017; 376:957-70.

v Taltz Summary of Product Characteristics.

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