Eli Lilly and Company®γ≈ announced today that the U.S. Food aσ☆nd Drug Administrati> on (FDA) has approved Taltz® (i&&♦xekizumab) injection 80 mg/mL for the treat♠♦ment of adults with active ankylosing spondylitis♣↓™ (AS), also known as radiographic axial spond≥÷✔yloarthritis (r-axSpA)​Ω×σ.This is the third in✘> dication for Taltz, w™¥​​hich was first approved by the FDA in March 20 ₩"☆16 for the treatment αλφof moderate to severe plaque psor₹₩iasis in adult patients who are candi♣∞§dates for systemic therapy or photo•♣₩therapy and then approved by thε☆∏σe FDA in December 2017 for th∑∑δ e treatment of adults with activeε  psoriatic arthritis."Ank> ☆↔ylosing spondylitis is a challenging di≠÷¶λsease that can cause se$←‍&vere back pain and if left untreated, ca‍γn significantly impact ≥∏↓πpatient mobility," said Rebecca Morison✘♠λ, vice president, U.S. Immunology at Lilly. "Weπ§ε are excited to now offer Taltz as ♠±™ a treatment option for people in need δφ​of relief from the sympt×¥γ☆oms of AS. This approval further ©↓€underscores Lilly's •™∑ commitment to helpin₩≈g people living with rheumatic di≥♠εseases."Taltz may be administe♥‌red alone or in combσ∞≈±ination with a conventional disea>&✘se-modifying antirheumati®§c drug (e.g. sulfasalazine), corticosteroδ‌∑ids, non-steroidal anti-inflamma∑±εtory drugs (NSAIDs) and/or analgesics. T★₩♣altz should not be used in patients w↔λith a previous serious hypersensitivity•‌↕, such as anaphylaxis, to ixekizumab or t↑♣o any of the excipients. €₩₩Taltz may increase the risk of ₹∏infection. Other war✔≈​nings and precautions for Taltzλ&≥  include pre-treatmentδ≈​ evaluation for tuberculosis, hype∞®'rsensitivity, inflammatory bowel diseλ∑₩ase, and immunizations. See Important Safety In‌<≤formation below.AS is a t♦™​ype of spondyloarthritis that affects the pelvi λc joints and spine, and can be charα∏×✔acterized by chronic inflammatory back paσ§★δin, stiffness and impaired function and ≤±mobility.1 AS is estimated to impact approximate☆✔ly 1.6 million people in the U.S.≈♥2"Having new treatme≈×nt options for the ankylosing spondylit¥¥is community is truly encouragin∏•✘Ωg," said Cassie Shafer, chief↔•→¶ executive officer of t≈$≠αhe Spondylitis Association of ₹$  America. "The ongoing focus to∑±£‍ help people impacted bλ∑£y the disease will hopefully lead us to an even€≥©δtual cure."The efficacy and‍β safety of Taltz in AS was dem​≤ ♥onstrated in two randomized, double-blind, place≥™<×bo-controlled Phase 3 studies t¶‌✘€hat included 657 adult patients<₹ with active AS: COAST-V in patients←→¶ who are biologic diseas"♥e-modifying antirheumatic≠" drug (bDMARD)-naïve and COAST-W in patients ☆•who previously had an inadequ↓​ate response or were intolerant t÷$≥o tumor necrosis factor (TNF) i✔★σ nhibitors.In both studies, the primary e€✔★∑fficacy endpoint was the proportion of patieγ÷¶Ωnts at 16 weeks achieving Assessγ‌♦♣ment of Spondyloarthriti✘£s International Society"§ 40 (ASAS40) response compareλ₩ d to placebo. ASAS40 mφλ©easures disease signs and symptoms <←≈such as pain, inflammation and λ‍≠"function. The COAST clinical tri'σ★δal program includes the first and only reg€Ωistration trials in AS to ε​ ♦achieve ASAS40 response at 16'≈ weeks as a primary endpoint. Result↓εs from both studies demonstrated tha∞∞≈×t patients treated with Taltz∏©✘σ achieved statistically significant and c‌€∏linically meaningful improvements i ‌↑n signs and symptoms, as de$₩←fined by ASAS40 response, compared ♥≈to placebo. At 16 weeks, pat‌‍ients achieved ASAS40 at the following response  πrates:COAST-V: 48 percent of patients treated ± ↕with Taltz every four weeks ver‍δ♣sus 18 percent of patients treated with pl<↓₽≠acebo (p<0.0001)COAST-W: 25 percent of patie  ©φnts treated with Taltz every four weeks ver←∏←sus 13 percent of patients treated with $¥™placebo (p<0.05)Additionally∑β✔₩, patients treated with Taltz demons♠®Ω∑trated statistically significant ÷↑improvements in key secondary endpoints in¥​♦♣ both studies, including the proportion oγσf patients at 16 weeks achieving ASAS20ε↕ at the following response rates:COAST-V: 64 p→↑≤ercent of patients treated wiα←th Taltz every four weeks versus 40 ‌ percent of patients treated with placebo (p=0.00 ¶≤™15)COAST-W: 48 percent of patients treated with T∏♣©§altz every four weeks versus 30 ≥♥percent of patients t÷ ​ reated with placebo (p<0.01)Oπ∞¶∞verall, the safety prφ™ofile observed in patients with AS treatedβ>≤ with Taltz is consistent with the safe♥λty profile in patients with psoriasis."Res≠≤ults from the Phase 3 clinical tri‌∞al program in ankylosing spondylitis showδ↓> that Taltz helped re∏​¥♣duce pain and inflammation and improve function i★£™n patients who had never been treated with a bDMε‍≠ARD as well as those who previous↓≈₽ly failed TNF inhibitors," said Phi☆±€÷lip Mease, M.D., Swedish Medical Center/Provi$↔'÷dence St. Joseph Health and University of♥÷  Washington. "This approval i&£s an important milestone for patients and ph£∞©$ysicians who are loo​¶king for a much-needed →≤alternative to address symptoms of AS."Lillyφ<≈ will work with insurer∏α>s, health systems and providers to §$< ensure patients are ab≈"↕le to access this tr✔ §eatment. Patients, physicians, pharmacists or"≤♣$ other healthcare prof¶πessionals with questions about T↓✘altz should contact The Lilly Answers Center at € 1-800-LillyRx (1-800•α<-545-5979) or visit w←↓ww.lilly.com.IndicationsTaltz is appλ®♥λroved for the treatment of adu≈≥lts with active ankylosin ←g spondylitis. Taltz  πis also approved for the treatment of adult←§×πs with active psoriatic arφ♥¶★thritis and adults w£↓≥ith moderate to severe plaqu↕×≤e psoriasis who are candidate±α>s for systemic therapy or pλ§∞λhototherapy.IMPORTANT SAFETδ>Y INFORMATIONCONTRAINDICATIONSTa♥✘§ltz is contraindicated in patients with a previo©∏≤us serious hypersensitivity reaction, such ≥'εδas anaphylaxis, to ixekizumab or to  ∞♣any of the excipients.WARNINGS AND PRECAUδ♥♠"TIONSInfectionsTaltz may increase the risk o™ε©f infection. In clinical trials of pat®✘₩ients with plaque psoriasis, the Taltz grou∑☆p had a higher rate of infections th ‍≤€an the placebo group (27% vs 23%). A simiλ ✘lar increase in risk o'αf infection was seen in placebo-control★ led trials of patients with psoriatic arthriti≠÷γs and ankylosing spondylitis. Serious in☆♣fections have occurred. Instruct patients to sδ"↕eek medical advice if signs or symptomΩ≥≠s of clinically important chronic€×π or acute infection occur. If a serious infect<₩≥₽ion develops, discontinue T✘©altz until the infection resolves.Pre-Tr"₩÷eatment Evaluation for TuberculosisEv₽δ≈aluate patients for tuberculosis σ₹∑(TB) infection prior to initiating treat®γ×∏ment with Taltz. Do not administer t↕∏o patients with active TB infection. Initiateα₹∞ treatment of latent TB prior to adminΩ♥istering Taltz. Clos¥÷ely monitor patients r> ∏♠eceiving Taltz for signs and s"↑σymptoms of active TB during and after treatme™××nt.HypersensitivitySerious hypersen ₹sitivity reactions, including angioedema and♠α< urticaria (each ≤0.1%), o‍↓Ω₹ccurred in the Taltz group in₩< clinical trials. Anaphylaxis, including case₹♥•s leading to hospitalization,λ& has been reported in post-marketing use with ♦≈βTaltz. If a serious hypersensit✘<♥ivity reaction occurs, discontinue Talt♠¥•z immediately and initiate appr©βopriate therapy.Inflammato≤≤ry Bowel DiseaseDuring T←"altz treatment, monitor"" patients for onset or exacerbations ♠σ≈ of inflammatory bowel disease.  ₹≈Crohn's disease and ulceratiγ∑✘ve colitis, including←™ exacerbations, occurred a∏δ¥t a greater frequenc₩™¥¥y in the Taltz 80 mg Q2W group (Crohn's d★'↓&isease 0.1%, ulcerative colitis 0.2¶↕∞÷%) than in the placebo group (0%) during cli ¶₽∞nical trials in patients with plaque psor✘∞☆σiasis and in the Taltz•÷ Q4W group in ankylosing spondylit♥±★is trials (Crohn's di$×↔★sease 1.0% [2 patients], ulcerative colitis 0.≥×±5% [1 patient]) than in the placebo grouε♦p (Crohn's disease 0.5%±Ω₽¥ [1 patient], ulcerative colitis >©0%). In the ankylosing spondylitis trials, seriouφ> s events occurred in 1 patient in the Taltz®∞λ♦ group and 1 patient in the placebo group.Immunγ↑σ×izationsPrior to initiating th≠™erapy with Taltz, con•£↑sider completion of all age-appropriate immuniza&∞tions according to current immunizati‍¥↕on guidelines. Avoid use of live v≈¥accines in patients treated with Taltz.∑≠♦♦ADVERSE REACTIONSMost com↕ mon adverse reactions (≥1%) associate©'∞♣d with Taltz treatment are injection site reacti↓↕∞Ωons, upper respiratory tract infectio♦ ns, nausea, and tinea infections£"¶. Overall, the safety profiles observed in &×δ∑patients with psoriatic arthritis and ¶≈ ankylosing spondylitis wer₽↔≠≤e consistent with the safety profile in paγ≈₩tients with plaque psoriasis, with the excepπ§÷≠tion of influenza and conjunctivitis in pso∞λ→riatic arthritis.Plea☆©→λse see full Prescribing Informa≤÷≤tion and Medication G↕↕€uide for Taltz. See Instructions for Use ★♣€↔included with the device.IX HCP ↓ ISI 23AUG2019About Taltz®Taltz® (ixek©↔izumab) is a monoclonal antibody that β↑Ωselectively binds with interleukin 17₩✘♣♦A (IL-17A) cytokine and inhibi♠‌γ ts its interaction with the IL-17§'↕↑ receptor. IL-17A is a naturally occurring c₹×ytokine that is involved in normal inflamma♥•$‌tory and immune responses. Taltz inhibits the✘¥♣σ release of pro-inflam€&♣matory cytokines and chemokines.About Lilly in I↕₽φ÷mmunologyLilly is bringing our he$♠ritage of championing groundbreaking,♦✘¥÷ novel science to immuno≤★λ↕logy and is driven to©₽ change what's possible for peo↑αple living with autoimmune diseases.↔↕Ω$ There are still significant unmet needs♣₩, as well as personal and societal ♦¥costs, for people living wi★×→£th a variety of autoimmune diseases and our goalπ®• is to minimize the burden o∞€±'f disease. Lilly is invest←₹φing in leading-edge clinica>>l approaches across our immunology portfoli&®o in hopes of transforming the ↕β✔§autoimmune disease treatment experi→‍δ★ence. We've built a deep pipeline and are focuse≈∏₩d on advancing cutting e≤€‌≈dge science to find new treatme₽α∏₩nts that offer meaningful improvemenσ↑αts to support the people and the communit∏ ↔ies we serve.About Eli Li™∏ φlly and CompanyLilly is a global h↔π÷↓ealth care leader that unites caring wi≠ε©th discovery to create mediδ÷cines that make life better for p∞"α☆eople around the world. We wΩ©ere founded more tha÷≈n a century ago by a man committed to α​creating high-quality medicines that≈<λ meet real needs, and today we remain true to th♠₽¶☆at mission in all our work. Across the‍× globe, Lilly employees wo♦∑≥≥rk to discover and bring life-changing medicine↔σs to those who need them, improve the undו★erstanding and management of disease, and giv₹♦δe back to communities throu₽§←§gh philanthropy and volunteerism. To learn®$  more about Lilly, please visit us at lilly.com δ δ→and lilly.com/newsroom.  P-LLYThiβ↑s press release contains for "≠÷ward-looking statements (as that term is de‌¥ fined in the Private Sec• €urities Litigation Reform Act of 1995) about ₹λ₩©Taltz (ixekizumab) as a treatmλγαent for ankylosing spondylitis, and reflects Li ♠lly's current belief. Howe™♥ver, as with any pharma'™ceutical product, there are substantial &π♣&risks and uncertainties in the process of d∑&evelopment and commercialization↔λ♠ . Among other things, the→‍δre can be no guarantee that Taltz will rec£"₽<eive additional regulatory approvals or be comm ®®ercially successful. For further discussionασ₩‌ of these and other risks and un&∞™certainties, see Lilly's most recent Form 10-K ÷‍₽€and Form 10-Q filings with the United States S↔∏λ₹ecurities and Exchange Commission. Except as re↑γquired by law, Lilly undertakes no d✔ε£✘uty to update forward-lookingφ'®σ statements to reflect events after the date o>​f this release.PP-IX-US-2♠↓←795 08/2019 © Lilly USA,∑≤± LLC 2019. All rights reserved. T♦÷λaltz® is a registered trademark owned or∑✔→§ licensed by Eli Lilly and Company, its sub&₩≠±sidiaries, or affiliates.from "✘pharma focus aisathe 2019 Asia-pa≥•‍cific Pharmaceutical IP L§₩£‌eader Summit will be h×λ&£eld in Beijing on&'$ nbsp;November 14-15, and will at₽✘tract more than 500 industry experts from domes™αtic and foreign pharmaceutic×≥φal companies, biotechnology companies, government‍≤≤s, associations, law firms, intellectual p÷ Ωroperty agents and other companies ∑←÷'to attend.Official re♦∑₽®gistration and consultation chan₹​γ<nels:Contact：AnnPhone: 021-65650305Email：♠πMarketing@zenseegroup.comhttp://σ∞©en.zenseegroup.com/p/510934/