Eli Lilly and Company announced today th☆✔ at the U.S. Food and Drug Administration (FDA) ↔σδhas approved Taltz® (ixekizumab) injectio↑♣×n 80 mg/mL for the treatment of adu∑​lts with active ankylosing s₩>pondylitis (AS), also known as radiographic ax€↓‌•ial spondyloarthritis (r-axSpA).This is the ∞€third indication for Taltz, which was fi¶λφrst approved by the FDA in March 2016 for the↕αγ treatment of moderate to severe plaquε↓>©e psoriasis in adultβ♣ patients who are candidates for s‍¥>ystemic therapy or phot​ ≈&otherapy and then approved by the FD•♣A in December 2017 for the treatmenβ€t of adults with active psoriatic arthrit←¥↓₩is."Ankylosing spondylit↕← ¶is is a challenging disease that can ca←φ use severe back pain and γβ♦'if left untreated, can significanβ©tly impact patient mobility," said Re↕∞σbecca Morison, vice president&<✘®, U.S. Immunology at Lilly. "We are ex✘§ ↔cited to now offer Ta£"∞ltz as a treatment option for €÷♥←people in need of relief from the symptom•§♠$s of AS. This approval further under♦"₹scores Lilly's commitment to helping people l≠∑♠™iving with rheumatic diseases."TaltzΩ∏λ₽ may be administered alone or i£<> n combination with a conventional disease-modify£¥ing antirheumatic drug (e.¶βg. sulfasalazine), corticosteroids, non-steroidal→€γ  anti-inflammatory drugs (NSAIDs) and/≈≥∑♦or analgesics. Taltz should not λ∏®be used in patients ×λ‍∑with a previous serious hype•<φrsensitivity, such a→ ₩s anaphylaxis, to ixekizumΩ​ab or to any of the excipients. Tal∏πα£tz may increase the risk of infection. Other"σ¥ warnings and precautions for Tal  ¥βtz include pre-treatment evaluation for tubercu™€σ∞losis, hypersensitivity, ↓♦★£inflammatory bowel disease, and immun÷♠izations. See Important Safet¶¥↓y Information below.ASγσ÷¥ is a type of spondyloarthritis that aff ‍±ects the pelvic joints and spine, and can be $÷β♠characterized by chronic inflammatory ba₩<ck pain, stiffness an☆®÷d impaired function and mobility.1 AS i≈÷→<s estimated to impact approximately 1.6 million pφδeople in the U.S.2"Having new t¥ ≈reatment options for the ankyloα≠≈sing spondylitis community is truly encouraging♦ ₹★," said Cassie Shafer, chief executive officer→>∞σ of the Spondylitis Association of Americ↕λ✘εa. "The ongoing focus to help people im✔←÷pacted by the disease will hopefully lead₽¥' us to an eventual cure."The efficacy and safe↑↔×ty of Taltz in AS was demonstrated in λ★‌two randomized, double§>×π-blind, placebo-controlledπ¥≥ Phase 3 studies that included 657 adult ↓>"patients with active AS: COAST-V in pa₩‍tients who are biologic disease-modifying anti∑λ"♥rheumatic drug (bDMARD)-naïve an£®×✘d COAST-W in patients who previously had an in↕♣​adequate response or were intolerant to tumo↔≈r necrosis factor (TNF) inhibitors.In both♦∞• studies, the primary ef↑₹♥ ficacy endpoint was the proport₽™§ion of patients at 16 weeks ac≠₩€ hieving Assessment of Spondyloarthritis ↑φ✘♣International Society π¶γλ40 (ASAS40) response co∑ ✔mpared to placebo. ASAS40 measures disease s ♦™igns and symptoms such as​•∑ pain, inflammation and function. The COAST Ω↔‍•clinical trial program includes the ©★¥​first and only regis∑•©tration trials in AS to achieve ASAS40 ‌ε∏™response at 16 weeks as♣'  a primary endpoint. Results from bo™∑β₹th studies demonstrated that♣≈÷→ patients treated with Taltz achieve÷$≥d statistically significant and clinα₽♣ically meaningful impr±✔λ ovements in signs and symptoms, as defined♦$©¥ by ASAS40 response, compared λε∞to placebo. At 16 weeks, patients achie↓ ved ASAS40 at the following response  δrates:COAST-V: 48 percent of pπ∑atients treated with Ta£λ←ltz every four weeks versus 18 percent§φ of patients treated with placebo (p&¶ lt;0.0001)COAST-W: 25 percent of p≤ atients treated with T≥δaltz every four week±δγ≈s versus 13 percent of patients treated™± with placebo (p<0.•✘γγ05)Additionally, patients treated wiδ≈→αth Taltz demonstrated≈< statistically signifiα∞cant improvements in key sec‍σondary endpoints in bo☆<✔®th studies, including the proportion oα¶♣ f patients at 16 wee₽λ↓ks achieving ASAS20 at the fo<™$llowing response rates:COAST-V: 64 percen​βt of patients treated with Taltz≠∏¶ every four weeks vers£π♠πus 40 percent of patients treated w↑✘↕♦ith placebo (p=0.0015)COAST-W: 48 percent of p‌♦atients treated with Taltz every f☆★♥our weeks versus 30 percent of patients ↕εtreated with placebo (ε§α♥p<0.01)Overall, the safety pro&✔file observed in patients with AS tλ≠♥™reated with Taltz is consistent ™×$σwith the safety profile in patients with psoriasiβ☆&∑s."Results from the Phase 3 clinical tri₽±al program in ankylosing spondylitis shoφ®w that Taltz helped reduce pain and inflam♠☆ Ωmation and improve function in patients who haε$αd never been treated witλ≥♣®h a bDMARD as well as thos​απe who previously failed TNF inhi♥★÷σbitors," said Philip Mease, M.D.,♦δ Swedish Medical Center/Providence St. £↕ε Joseph Health and Universit♠→•y of Washington. "This approval ✔→is an important milestone for patients and phy×$×sicians who are looking for a much-ne₩♠$eded alternative to addr$₩"★ess symptoms of AS."Lilly will work with♣≈ insurers, health sysφ ★tems and providers to ensure patients are able to€©↑& access this treatment. Patients, ph‍∑ysicians, pharmacists or ε≥other healthcare profess≠₽ionals with questions about Tal​☆"tz should contact The Lilly Answers Center at ≈©​₹1-800-LillyRx (1-800-545-5979) or viπ​₽sit www.lilly.com.IndicationsTalt ‌$z is approved for the treatmeΩ<σnt of adults with active ankylosing spondyliti★λπ±s. Taltz is also approved for the tre÷∏↑'atment of adults with active psoriatic arthriti£§☆s and adults with moderate tγ©£γo severe plaque psoriasis who ≥σare candidates for system'<ic therapy or phototherapy.IMPOR ♥σ∏TANT SAFETY INFORMATIONCONTRA♣♥÷INDICATIONSTaltz is contraindiλ₩↕λcated in patients with a previous serious hypers₹‌ensitivity reaction, sucγ≥h as anaphylaxis, to ixeα​←kizumab or to any of the excipi₹∞ •ents.WARNINGS AND PRECAUTIONSInfectionsT≥∑→altz may increase the risk of infection. In δ↑<"clinical trials of patients with plaqφ> ♠ue psoriasis, the Taltz group had a high ∏≈×er rate of infections than the placebo g← roup (27% vs 23%). A similar i∏♣™ncrease in risk of infection was see&$n in placebo-controlled trials δ÷₩of patients with psoriatic arthritis≈© and ankylosing spondylitis. Serious infections h±∞ave occurred. Instruct p↕φ♥←atients to seek medical a✔∞dvice if signs or sy₩•>mptoms of clinically i&÷φγmportant chronic or acute infection occur. If♠ Ω a serious infection ♣∑<develops, discontinue Taltz until theπ±↓​ infection resolves.Pre-Trea→σ‍tment Evaluation for TuberculosisEvγφaluate patients for "₽•tuberculosis (TB) infection prior to initiating t←σ‌reatment with Taltz. Do not administe←™∞εr to patients with act≤×ive TB infection. Initiate treatment of latentδ₩σ TB prior to administering Taltz. Closφ&×ely monitor patients receivin ₽g Taltz for signs and symptoms of active TB d¥∞₩"uring and after trea♥§tment.Hypersensitivit↕÷'ySerious hypersensiti ≥vity reactions, including an₩→↓∏gioedema and urticaria (each ≤0.1%),β←₹ occurred in the Taltz group in clinical trials.∞• Anaphylaxis, including cas±≤★÷es leading to hospitalization, ha↑←¥€s been reported in post-marketing use with Taltzε♣ ®. If a serious hypersensitivity reaction o÷×'↕ccurs, discontinue Taltz immediately and initiat≤‍∑←e appropriate therapy.Inf♠≤  lammatory Bowel DiseaseDuring Taltz tr€'σ eatment, monitor patients for onset or exac$​erbations of inflammatory bowel diseas♣↑™e. Crohn's disease and ulcerative colitis, in↑βπcluding exacerbations, occurred at a greate∑"♠•r frequency in the Taltz₽← 80 mg Q2W group (Crohn's diseaλ∑€se 0.1%, ulcerative colitis 0.2%) th↕© ↕an in the placebo groα ♣up (0%) during clinical trial÷€ ‌s in patients with plaque psoriasis and in ₽✔™the Taltz Q4W group in ankyl↓'osing spondylitis trials (Crohn's disease β✘•1.0% [2 patients], ulcerative colitis 0.5% $∏©[1 patient]) than in the placebo group (Crohn≈™γ's disease 0.5% [1 patient], ulπ♥φ cerative colitis 0%). In the ankylosi₩'ng spondylitis trials, serious events o¶÷±ccurred in 1 patient in the Taltz ±§♠group and 1 patient in the placeboπ"• group.ImmunizationsPrior to initiating therapy ✔ ¥with Taltz, consider completion of all age ↔-appropriate immunizations accordi÷¶ng to current immunization guidelines. Avoid¶≈€π use of live vaccines in patients tr φ§eated with Taltz.ADVERSE REACTIONSMos™¥t common adverse reactionα"s (≥1%) associated with Taltz treatment ar✘→↕Ωe injection site reac¥§tions, upper respiratory tract inf•>₹→ections, nausea, and tinea i♥¥&≤nfections. Overall, the safety profiles obseεγ↓<rved in patients with psoriatic arthri'₩λ tis and ankylosing spondylitis were consi★ ÷stent with the safety profile in patien≠ ts with plaque psoriasis, w✔♥∞♠ith the exception of influenza and ₩‌conjunctivitis in psoriatic art ♥hritis.Please see full Pr♣ <αescribing Information and Medica'•tion Guide for Taltz. See Instructions for Use in&αcluded with the devic€"e.IX HCP ISI 23AUG2019About Taltz®T∑♦altz® (ixekizumab) is a monoclonal antibody tha©'™✘t selectively binds with interleukin 17A±§ (IL-17A) cytokine and inhibits itγ₩≈s interaction with the IL-17 receλλptor. IL-17A is a natura↕♦ lly occurring cytokine that is involved in norma♦'♣‌l inflammatory and immune responses.₽•♠  Taltz inhibits the rel∏≤₩♥ease of pro-inflammatory cytokines and cheφ←♣↔mokines.About Lilly in ImmunologyLilly is brσγ∞₽inging our heritage of champioλ✔ning groundbreaking, nov★←el science to immunology←∏ and is driven to change what's possible for peop÷$€le living with autoimmune dis​εeases. There are still significant unmet§₹€φ needs, as well as personal a"≠nd societal costs, for people living with a ♦φβvariety of autoimmune diseases aπ​nd our goal is to minimize the burden π↑ ​of disease. Lilly is investing in lead ≈∑ing-edge clinical approaches across‍↑↓ our immunology portfolio in≠π÷ hopes of transforming the autoimmune©↑π disease treatment experienγγ✘®ce. We've built a deep pipeline an↓♦✔$d are focused on advancing cutting edge sciencβ×e to find new treatmen≈♥‍"ts that offer meaningful impro×εvements to support the people and the commλ&unities we serve.About Eli Lilly♦±<→ and CompanyLilly is a global health ca←÷&re leader that unites caring with dis↓λ♣covery to create medicines that make life ©&≈better for people around the world. We↓≤¶ were founded more than a century ago b‌™£y a man committed to creating high↓∑-quality medicines that ÷©meet real needs, and t→§<♣oday we remain true to that mission in alα₹≠l our work. Across t★ε≤he globe, Lilly employees work to discover a€☆nd bring life-changing medicines to those who'•≠® need them, improve the understandi♥©↑ng and management of disease, and give ‍♦back to communities throug÷∑ασh philanthropy and volunteerism. To learn σ©♦ more about Lilly, please visit us at™γ> lilly.com and lilly.com/newsroom.  P-LLYThi ®βs press release contains forward-☆±‍looking statements (as that term δφδis defined in the Priv∑→¥∞ate Securities Litigation Reform Act o§"f 1995) about Taltz (ixekizumab) as a treatmen₩®♠t for ankylosing spon¥∏↓γdylitis, and reflects≠×π↑ Lilly's current belief. Ho​$×wever, as with any pharmaceutical product, there ★↔σare substantial risks and uncertain≈¥×ties in the process ofσ' development and commercial≈ →​ization. Among other thi&>ngs, there can be no•∞ guarantee that Taltz will receive additional r∑✘γegulatory approvals or be commerc" ‍ially successful. For furt♣©‌her discussion of these and φ↔£∞other risks and uncertainties, see Lilly's m‌↑"‍ost recent Form 10-K and Form 10-Q filings wΩ↓ith the United States Securities and Exchaφ∏♦nge Commission. Except as required by law, Lil$₹ly undertakes no duty to update forward-l← ooking statements to‌" reflect events after the date of this release"•₽π.PP-IX-US-2795 08/2019 © Lilly USA, LLC 2019. All←​ rights reserved. Taltz® is¶∞γ¥ a registered trademark owned or licen♦™≈sed by Eli Lilly and Company,ε≥‍ its subsidiaries, or affiliates.from p ≥‍harma focus aisathe 2019  ♠←λAsia-pacific Pharmaceutical IP Le≥φ≈ader Summit will be held i♣↑ n Beijing on&n​←∞bsp;November 14-15, and will∞∞ attract more than 500 indust↓™ry experts from domestic✔'♦ and foreign pharmaceutical companies, biotechn♠←™∞ology companies, governm×‍ents, associations, law firms, intellectual propeλσ✘'rty agents and other companies to ♣☆β"attend.Official registration and cons₩‌≈σultation channels:Contact： ↑‌AnnPhone: 021-65650305Email：Marketing@β‍zenseegroup.comhttp://en.zenseegroupα±₽.com/p/510934/