Eli Lilly and Company announced™>∞ today that the U.S. Food and Drug Administraα≥"tion (FDA) has approved Tβ☆÷♦altz® (ixekizumab) injection 80 mg/mL fo​ ≤¶r the treatment of adults with active ankylosing ♣®✔>spondylitis (AS), also known as radiogr↔ aphic axial spondyloarthritis (r-axSpA).This δ€<is the third indication for Taltz, which was fiε€∏rst approved by the ↑≈→ΩFDA in March 2016 for the treatment of moderatα®e to severe plaque psoriasis÷ ≥ in adult patients who are ×♥candidates for systemic therapy or ph​₹ototherapy and then approved by the FDA in Decem$¶ber 2017 for the treatmeλ§≠✘nt of adults with active psoriatic arthritis."An©​kylosing spondylitis is a challen<¶≤ging disease that can cause severe ba♣$♣ck pain and if left untreated, can sλφ™πignificantly impact patient mobility," saiδ≈↕d Rebecca Morison, vice preside↕δnt, U.S. Immunology at L♣λ↑≤illy. "We are excited♦→♥ to now offer Taltz as a treatment option for pe∞↕σople in need of relief from the symptoms of AS. T¥↑€•his approval further underscores Lilly's commitm↔§ent to helping people living with∏∏© rheumatic diseases."Tal₽₹↔tz may be administered alone or in com↕±bination with a conventional diseaπ ¶se-modifying antirheumatic drug (e.g. sulfasa♣'lazine), corticosteroids, non-steroidal ∑♣"₽anti-inflammatory drugs (NSAIDs) and/or analgesi♠™≠'cs. Taltz should not be used in patient₩≤π←s with a previous se< rious hypersensitivity, such as anaphylaxis, ☆¶to ixekizumab or to any of the excipients. Taltz βΩπmay increase the risk of infection. Other wa€★✘rnings and precautions for Taltz in‍♦clude pre-treatment evaluation f↔> £or tuberculosis, hypersensitivity, inflammat₩α¥ory bowel disease, and immuε>nizations. See Important Safety In±>✘±formation below.AS is a type of spond©$yloarthritis that affects the pelvic jo€♠≤ints and spine, and can be characterized by chron€<δic inflammatory back pain, stiπ♠∞ffness and impaired function a♦&≈nd mobility.1 AS is estimated to impα‍±act approximately 1.6¶₹ million people in the U.S.2"Having ₽∑β≥new treatment options for the ankylosing sp∑✘αondylitis community is truly encouraging,"‍<β☆ said Cassie Shafer, ≠≥♥chief executive officer of the Spondy∏δlitis Association of Am>≤÷✘erica. "The ongoing focus to help÷☆★♥ people impacted by thε✔★e disease will hopefullδ→y lead us to an eventual cu∑≈&→re."The efficacy and safety of Taltz in ∏ ¶♦AS was demonstrated in two randomized, double-bl★±"ind, placebo-controlled Phase 3 ‌♦π©studies that included 657 adult patients wit♣'β↓h active AS: COAST-V ♣φ§in patients who are biologic disease-modifying≠& antirheumatic drug (bDMARD)-naïvλ©e and COAST-W in patients who previously had aδ♥®&n inadequate response or were intolerant to tΩ↕≠umor necrosis factor (TNF) inhibit×←εors.In both studies, the primary eff≥♣icacy endpoint was the prε ¶oportion of patients at 16 weeks achieving Aγ♣>ssessment of Spondyloarthritis International Soci≈★☆ety 40 (ASAS40) response compar♥φed to placebo. ASAS40   λ÷measures disease signs and sym±∑αptoms such as pain, inflammation δφ★and function. The COAST clinic≥σ‌≠al trial program includπα♣es the first and only registration trials in AS ≤ α∞to achieve ASAS40 response©♥€ at 16 weeks as a primary endpoint. Results from λ$©¶both studies demonstrated t∏ε↔hat patients treated with Taltz achieved statisti≠≤¶cally significant and clinically meaββ₹ningful improvements i₩λ★n signs and symptoms, as defin★ ‌γed by ASAS40 response, compared to placebo. At ♣λ16 weeks, patients ac₩♥  hieved ASAS40 at the fo‍βllowing response rates:COAST-V: 48 percent of pa ₩↓✔tients treated with Taltz every♠✘ four weeks versus 18 perce≥ πnt of patients treated with₹≠♠' placebo (p<0.0001)COAST-W: 25 peγ®∏rcent of patients treated≠¶♣€ with Taltz every four ♣↑weeks versus 13 percent of patients treated ∞±¥with placebo (p<0.05)Additionally, pa'∞tients treated with Taltz demonstrated  ¶♦statistically significant improvemenα¥↓₩ts in key secondary endpoi‍'↕nts in both studies, including the proε☆★​portion of patients at 16 weeks ac¶±hieving ASAS20 at the fol"←₽÷lowing response rates:COAST-V: 64÷™ percent of patients treated with Taltz every fou≠→ r weeks versus 40 percent of patients t₩∞₽£reated with placebo (p=0.0γβ✘015)COAST-W: 48 percent of pa↓₹tients treated with Taltz every four weeks versus♦∞£★ 30 percent of patients treated with pl ♠ε acebo (p<0.01)Overall, the safety profile↕>‌§ observed in patients with AS treated wit≈'h Taltz is consistent with the safety pr'♥£$ofile in patients with psoriasis."Results fro¶‌∞m the Phase 3 clinical<∏ trial program in ankylosing spondylitis show t$♦hat Taltz helped red←↓uce pain and inflammati≥"↕on and improve function in patients w±₹ho had never been treated with a bDMARD as wel‍ ≠₹l as those who previously failed TNF✔βλ inhibitors," said Philip Mease, βε↔×M.D., Swedish Medical Center/P₩‍÷★rovidence St. Joseph H♣∏ealth and University of Washington. "This ap•☆proval is an important milestone for patients and• ​δ physicians who are looking fo✔ε↓r a much-needed alternatσ ₽ive to address symptoms of AS."Lilly wi₹  ‍ll work with insurer±♥s, health systems and pro≤πviders to ensure patients are able to accαπess this treatment. Patients, physicians, p≥≥≤harmacists or other healthcare professionals wi★&th questions about Taltz should contac$≠​t The Lilly Answers Center at 1-800-LillyRx (1-★"✔800-545-5979) or visit www.lilly.com.IndicationβΩ'εsTaltz is approved for the t•☆"reatment of adults wi×→>th active ankylosing spondylitis. Talt§​÷™z is also approved for the tre₹≠atment of adults with a☆​♥ctive psoriatic arthritis and adults with mode ε™rate to severe plaque÷δ ¥ psoriasis who are candidates for systemic ther♠∑"Ωapy or phototherapy.IMPORTANT SAFETY INFORMAT‌↔IONCONTRAINDICATIONSTaltz is contraindicate₽π¥÷d in patients with a previous ser↓λ↑ious hypersensitivity reaction, such as anaphyl¶₩£↔axis, to ixekizumab or to any of t✔₽₹<he excipients.WARNINGS ¥$AND PRECAUTIONSInfectionsTaltz may increase ​↓αthe risk of infection. In clinical trials of pat™Ωients with plaque psoriasis, the Taltz groupλ←​✔ had a higher rate of β&>infections than the placebo group (27% vs 2α•3%). A similar increase in ris₽ k of infection was seen in plac‌←♦§ebo-controlled trials of patients with ₹§psoriatic arthritis and ankylosing spondylitis.↑>∞∞ Serious infections have occurred. Instru₹→∞‌ct patients to seek medical advice if $≥ signs or symptoms of clinically import©‌÷∞ant chronic or acute i'≈£πnfection occur. If a serious infeαα$ction develops, discontinue Taltz until the₽γ infection resolves.Pre-Treatment Eval÷↓uation for TuberculosisEvaluate patients for α© ★tuberculosis (TB) infection prio→&×‌r to initiating treatment with Taltz. Do not ₽∑‌administer to patients with activ€★e TB infection. Initiate treatment of latent TB φ∏‍←prior to administering Tλ&∏→altz. Closely monitor patients receivinγ£↓g Taltz for signs and symptoms of active TB du♣™φring and after treatment.Hypersensitiv₽÷itySerious hypersensitivity rΩ׶eactions, including anγ☆gioedema and urticaria (each ≤0.1%), occurre≤★‌​d in the Taltz group in clinical trials. A&✔↕ naphylaxis, including cases leading to hospit ↓∑alization, has been reported in pλ©₩ost-marketing use with Taltz. If a seσ‍rious hypersensitivity reaction occ¥φurs, discontinue Taltz immediately★↕♠ and initiate appropriate therapy.I♥‌nflammatory Bowel DiseaseDuring Taltz tre&←₹atment, monitor patients for onset or exa÷♥cerbations of inflammatory bowel diseas←↑δ♠e. Crohn's disease and ulcerative colitis, i​€©ncluding exacerbatioα÷¶₹ns, occurred at a greater •βfrequency in the Taltz 80 mg Q2W group (←§↔Crohn's disease 0.1%, ulcerativeλ  colitis 0.2%) than in the placebπ≥₽o group (0%) during clinical trials φβin patients with plaque psoriasis and in the Tal≤ π✔tz Q4W group in ankylosing s↔∞±♦pondylitis trials (Crohn's disease ‌ ♣‌1.0% [2 patients], ulcerative colitis 0.5% [1 pat'≥γient]) than in the placebo group (Croh✘≥n's disease 0.5% [1 patien‌★t], ulcerative colitis 0%). In the ankylosing s≠€$pondylitis trials, seriousαβ✔ events occurred in 1 patient in the Talt≥£ ♠z group and 1 patient in the placebo ‌×​group.ImmunizationsPrior to↓±™ initiating therapy with Taltz, consider comple☆€tion of all age-appro£↑≤÷priate immunizations♥>≠ according to current immunization gu→¥idelines. Avoid use of live vaccines in pat​φients treated with Taltz.ADVERSE REACTIONSMost cα☆φ↓ommon adverse reactions (≥1%) associateφ★d with Taltz treatment ar‌λe injection site reactions, upp♦₹✘φer respiratory tract infections, nausea, a♥≥​♥nd tinea infections. Overall, the safetyγ‌↓★ profiles observed in patients with pso♥₩riatic arthritis and ankylosin≥♦✔‍g spondylitis were consisλγ πtent with the safety profile in patients with p¥₹$₽laque psoriasis, with ♥•the exception of influenza and conjunct♥↕×∞ivitis in psoriatic arthrit↓♣is.Please see full Prescribing Information a÷ Ω★nd Medication Guide for Taltz. See Instructions fγ γor Use included with the device.IX ✔"☆♠HCP ISI 23AUG2019About Taltz  ♣®Taltz® (ixekizumab) is a monocl§↓onal antibody that sσ↑electively binds with interleukin © ♦17A (IL-17A) cytokine and inhibits its interact¶≥₩ion with the IL-17 receptor. IL-1‍γ±7A is a naturally occurr®→ing cytokine that is involved in no♣↔±rmal inflammatory and immune responses. T∑‌> altz inhibits the release of pro-inflammatory c↔®δ ytokines and chemokines.About Lil✔§∏ly in ImmunologyLilly is bringing our herit ε↓↕age of championing groundbreaking, novel&∑✘∞ science to immunology and i≥σs driven to change what's possible for §£>people living with auto≈↓immune diseases. There are still significant un♦ met needs, as well as personal and societ ≠♣al costs, for people living with a variety o≠↓f autoimmune diseases ✔∑and our goal is to mi& ₹nimize the burden of d₽εisease. Lilly is invλ≥↔₽esting in leading-edge clinical approacheβ≤s across our immunology portfolio in hope‌&↓s of transforming the  $¥autoimmune disease t&≠÷reatment experience. W≠₩∞©e've built a deep pipeline and are focused ☆≤≤↕on advancing cutting edge sciencπεe to find new treatments that offer→¶> meaningful improvements to support the pe£•>ople and the communities we serve.About Eli L'ε∏βilly and CompanyLilly is a g∏βlobal health care leader t¶±♠δhat unites caring with discove§₹☆ry to create medicine∑≠©s that make life better for peo₽€ple around the world.  ≤We were founded more than aα¶☆λ century ago by a man committed∑'∑ to creating high-quality medicines that mee  t real needs, and today we r™ πemain true to that miss₹≈‍≈ion in all our work. Across th↓​↓'e globe, Lilly employees work to d•""iscover and bring life-ch¥♦←anging medicines to those who need&↔★ them, improve the unders§♠tanding and management of disease, and give back₽₩×≠ to communities through p±×₽↕hilanthropy and volunteerism.≠$≥ To learn more about   Lilly, please visit us at lilly.com σ≤$♣and lilly.com/newsroom.  P-LL∏¶✘YThis press release contains forwarα•d-looking statements (γ∏as that term is defined in the Private Securi™✘ties Litigation Reform Act of 1995) a•♦≥£bout Taltz (ixekizumab) as a tr☆★eatment for ankylosing spondylitis, and re<←✘flects Lilly's current bα‍φelief. However, as with any ¶♦γpharmaceutical product, there‍​ are substantial risks and uncertaint✔±♥ies in the process of devel™♣♣opment and commercializatio♥♣n. Among other things, there can be no€§≠ guarantee that Taltz will rece>¶>ive additional regulatory ap>δ•provals or be commercially §®successful. For further discussion of these and∞✔ other risks and uncertainties, see Lilly's mos¥‍t recent Form 10-K and Form 10-Q filings with theδ<↑ United States Securities and∞±₩ Exchange Commission. Ex★↓∞ cept as required by law, Lilly undertakes no ₹ duty to update forward-looking statements to αγ®®reflect events after t>↕₩he date of this releas©←e.PP-IX-US-2795 08/2019 © Lilly US&↓‍A, LLC 2019. All rights reserved.γ✔ Taltz® is a register  λed trademark owned or licensedλ↔ by Eli Lilly and Compan>✔&y, its subsidiaries, or affiliates.from pharma  ♠≈focus aisathe 2019 Asia-pacific Pharm'→σ>aceutical IP Leader Suφ≈©δmmit will be held in Beijing&σ↔nbsp;on November 14-15, and will attφΩα↓ract more than 500 industry experts fr♦↓∑om domestic and foreign pharmaceutical'™> companies, biotechnology companies♦✔♦ε, governments, associations, laα∞w firms, intellectual prop∑₹erty agents and other companies to attend.O>¥ →fficial registration and consultπ©ation channels:Contact：AnnPhone↑¶≠: 021-65650305Email：Marketing@zensδ₹>eegroup.comhttp://en.zensee ♣↔♠group.com/p/510934/