Eli Lilly and Company announced today that ✘₽☆¶the U.S. Food and Drug Adminiφ♥stration (FDA) has appr ¥•‍oved Taltz® (ixekizumab)γ£ injection 80 mg/mL for the tr£ eatment of adults with active ©¶£ankylosing spondylitis (AS), al♦£∞so known as radiographic axial spondyl •✘oarthritis (r-axSpA).This is the third indicaγ₽®tion for Taltz, which was first approved<δ by the FDA in March 201≈✔6 for the treatment of moderate to severe plaque‌δ psoriasis in adult patients who are c>£"andidates for systemic t÷¥®∞herapy or phototherapy and then approve∏"♦¶d by the FDA in December 2017 for the treatmen←↑​∑t of adults with active€&¶ psoriatic arthritis."Ankylosing spondylitis i>" Ωs a challenging disease that can cause severe bac™≤λk pain and if left untreated, ♣δcan significantly impact patient mob₹<∑§ility," said Rebecca Morison, vice >×↕®president, U.S. Immunology at ♠φLilly. "We are excited to now offer Taltz∏∏ as a treatment option for people in ≈₩need of relief from the symptoms of AS. This a÷✔↓pproval further undersc←↕≈ores Lilly's commitm§$×ent to helping peopl"♦→e living with rheumatic diseases."Ta→≤•↔ltz may be administer±£ed alone or in combinatio ♥§n with a conventional disease-modifying antirheu↓>☆♥matic drug (e.g. sulfaΩ"≥salazine), corticosteroids, non-steroidaα∑ l anti-inflammatory drugs (NSAIDs) ✔φand/or analgesics. Talt♣↕z should not be used in patients with a previous ​•serious hypersensitivity, suc≥ h as anaphylaxis, to ixek≠€izumab or to any of the excipients. Taltz"↑ may increase the risk of infectiδ×↑on. Other warnings and precautions for Taltz incl≤Ω§ude pre-treatment evaluation for tuberc€§<ulosis, hypersensitivity, inflammatory bowel dis♣'✔αease, and immunizations. See Important Safety I≥≤nformation below.AS is a type​   of spondyloarthritis that affects & ₹the pelvic joints and spine, and can be cha≤>racterized by chronic inflammatory back pain, stiδ$•ffness and impaired function and mobilit✔<y.1 AS is estimated to →δ♠impact approximately 1.6 ≥  ☆million people in the U.S.2"H£‌←aving new treatment options for the ank₹©ylosing spondylitis community is truly encα ouraging," said Cassie Shafer, chief executive ±♠officer of the Spondylitis Associationφ₹×≈ of America. "The ongoin↑γ∏σg focus to help people impac∞<∏γted by the disease will hopefully l÷αead us to an eventual cure."The effδλ​icacy and safety of Taltz in AS was demonstrat₩φΩεed in two randomized€₩∞Ω, double-blind, placebo-controlled Phase 3 studie→♥s that included 657 adult patients with active ∑λ☆AS: COAST-V in patients who are biologic↑•∑¥ disease-modifying antirheumatic d₹​↑↔rug (bDMARD)-naïve and COAΩ ST-W in patients who previously had an inadequa>‌★ te response or were intolerant to tumor✔∞ necrosis factor (TNF) inhibitors.In both stuγ↑<•dies, the primary efficacy endpoint was the propo ¶εrtion of patients at 16 weeks achieving₽≥ Assessment of Spondy™★ γloarthritis International Society 40 (ASAS40) resγ&π≥ponse compared to placebo. ASAS40 m≠>easures disease signs and symptoms su&≈ch as pain, inflammation and function.δ  The COAST clinical trial program✘>α includes the first and only regi±↑stration trials in AS to achieve ASAS40 re‍≈™↕sponse at 16 weeks as a primary endpoint. Re©♦↑ sults from both studies demonstrated th$β™at patients treated with ‍★★Taltz achieved statistically significant and c★×linically meaningful improvements i♠"‌εn signs and symptoms, as defineγ¶ ≥d by ASAS40 response, compared to  ↑≥placebo. At 16 weeks, pa&σtients achieved ASAS40 at$∏​ the following response rates:COAST-V: 48 percβΩent of patients treated with Taltz every four wee←↔ks versus 18 percent of ♠>αΩpatients treated with placebo (p<0.0001)COδ§≤∏AST-W: 25 percent of patients treated wit'‍₹βh Taltz every four we↑£​→eks versus 13 percent of patients ✘ treated with placebo (p&l ®☆πt;0.05)Additionally, patients trea↕≠ted with Taltz demonstrated stati¶"stically significant improvementπ♦∑s in key secondary endp±≠oints in both studies, inclα>uding the proportion of patients at 16 week€∑↕♥s achieving ASAS20 at the following reΩ♣₽sponse rates:COAST-V: 64 percent of pati​φ←✘ents treated with Taltz eveβ∑♠φry four weeks versus 40 percent of patients ÷δ§treated with placebo (p=0.0015)COAST-W: 48♠©  percent of patients treated with Taltz ev≥£☆λery four weeks versus 30 per≠∑÷cent of patients treated with p↓✔lacebo (p<0.01)Overall, ←♦ ♦the safety profile observed in pat✔≈© ients with AS treated withφ×< Taltz is consistent with the§∏$ safety profile in patient≠≈•©s with psoriasis."Results from ±¶πthe Phase 3 clinical trial program in ankylosi★π♠Ωng spondylitis show that Tφ↔altz helped reduce pain and inflammation and ∞'"↓improve function in pat"✔≈ients who had never been tre←↑≤βated with a bDMARD as well as those who prev÷≈'iously failed TNF inhibitors," said Philip Meas$∏☆e, M.D., Swedish Medical Center/Provide÷ nce St. Joseph Health and University of Washi↑£§☆ngton. "This approval is an impo×‍rtant milestone for patients and physicians who‌‌← are looking for a much-needed alternative to add•±ress symptoms of AS."Lil★₹•ly will work with insurers, health systems ™δ≠βand providers to ensure patients ←↑↓are able to access this treatment. P ≈atients, physicians, pharmacists or o↔☆ther healthcare professioα↑™nals with questions about Taltz should co→≠↓ntact The Lilly Answers Cente♠¥÷∏r at 1-800-LillyRx (1-800-↔↓βσ545-5979) or visit www.lilly.com.Ind↓↓"↔icationsTaltz is approφφδ♦ved for the treatment of '‍&adults with active an®♥α​kylosing spondylitis. Taltz is also approved  σ↓​for the treatment of adults with active pso< £riatic arthritis and♦÷↓♠ adults with moderate to severe plaqπ≠>♣ue psoriasis who are can≈♣ε→didates for systemic therapy or phototherapΩΩ≤y.IMPORTANT SAFETY INFORMATIONCONTRAINDICATIΩΩ₽₽ONSTaltz is contraindβεicated in patients with a previous serious h§‍≥ypersensitivity reaction, such ∞•✘εas anaphylaxis, to ixekizumab or to any of >♣§$the excipients.WARNI ∏NGS AND PRECAUTIONSInfectionsTaltz ±•may increase the risk of infection.©§₹ε In clinical trials of patie ¥nts with plaque psoriasis, t↔  he Taltz group had a higher rate of infection↔♣s than the placebo group (27% vs 23%). A s σimilar increase in risk of infection was seen ®<in placebo-controlled tria•$±ls of patients with psoriatic arthritis a&←nd ankylosing spondylitis. Serious infectionsλ™≤ have occurred. Instruct patients α↔λto seek medical advice if signs or sympπ₹≥φtoms of clinically import•‌♦ ant chronic or acute infection occur. If a serδ"ious infection develops, discontinue Taltz un<Ωtil the infection resolves.Pre-Treatmen →<t Evaluation for TuberculosisEvaluate pφ ≥↔atients for tuberculosi≠÷s (TB) infection prior to i®↓÷nitiating treatment with Ta☆βltz. Do not administer to patients wit∞≤₹h active TB infection. Initiate t∞↔πreatment of latent TB p∞•rior to administering Taltz. C♣¥÷↓losely monitor patients receiving Talt♣₩π≈z for signs and symptoms of active TB d¥∞→↑uring and after treatment.Hypersensiti&£©vitySerious hypersensitivity rε✘™eactions, including angioedema an¥₩↕d urticaria (each ≤0.1%), δ≤✘∞occurred in the Taltz group γ↕in clinical trials. Anap✔λ★ hylaxis, including case≠×s leading to hospital♦πization, has been reported in post-maαδ≈₽rketing use with Taltz. If a serious₽π hypersensitivity reaction occur∏>γ's, discontinue Taltz immediate​↔♠ly and initiate appropriate therapy.Inf♥♦☆lammatory Bowel DiseaseDuring Ω♠Taltz treatment, monitor patients for oδ♣nset or exacerbations of inflammatory bowel diseΩ≥∏$ase. Crohn's disease and‌" ulcerative colitis, including←'÷₽ exacerbations, occurr★$Ωed at a greater frequency in the Taltz 80 mg Q2Wβε group (Crohn's disease 0.1%, ulcerat$•ive colitis 0.2%) than in the pla₹ cebo group (0%) during clinical trialsγ  in patients with plaque psoriasis and in th♠≥φ¥e Taltz Q4W group in ankylosing spo'€​ndylitis trials (Crohn's disease 1.0% [2 pΩ>™atients], ulcerative colitis 0.5%&↕ [1 patient]) than in th& σ☆e placebo group (Crohn's disease 0.5% [1 pati♥α♥♥ent], ulcerative colitis 0%). In the anky​εlosing spondylitis trials, serious events occurr&∏λ©ed in 1 patient in the Taltz group and 1σ∑ patient in the placebo group.Immunizatio™ εnsPrior to initiating therapy with "©Taltz, consider complαα☆≤etion of all age-appropriate immunizat£¥‌ions according to cu∏‍rrent immunization guidel®₽★>ines. Avoid use of li±​  ve vaccines in patients treated with Taltz.☆÷✔↔ADVERSE REACTIONSMost ☆​common adverse reactio'¶ns (≥1%) associated with Taltz tr★≤eatment are injection site reactions<φ', upper respiratory tra↕¶>ct infections, nause‍±a, and tinea infections. Overall, the safΩ☆ety profiles observed in patients₽£•₹ with psoriatic arthritis and ∏<¥δankylosing spondylitis were consistenΩ★βδt with the safety profile ↑σ" in patients with plaque psoriasis,  φwith the exception of influenza and conjunctiviti₹λ‌s in psoriatic arthritis.Please see <®•​full Prescribing Information and Medica•≤₹tion Guide for Taltz. See Inst÷​ ructions for Use included with ♣'☆‍the device.IX HCP ISI 23AUG2019About T φ§•altz®Taltz® (ixekizumab) is a monoc♠↓∞×lonal antibody that φπ∞≠selectively binds with interleukin 1÷$↔7A (IL-17A) cytokine and inhibits its interac∑♠tion with the IL-17 receptor. IL-17A i♠₽βs a naturally occurring cytokin​ e that is involved in normal inflammatory and ™≠immune responses. Taltz inhibits the release of p∑γro-inflammatory cytokines and chemokines.Ab±₽₹∑out Lilly in ImmunologyLi≤÷πlly is bringing our heritage ₹γof championing groundbreaking, novel✘‌ science to immunoloφ"gy and is driven to change what's possible→☆  for people living with autoim÷ mune diseases. There are still significant'§™≤ unmet needs, as well as peε♠rsonal and societal costs×♣'≈, for people living with a variety of ©♥ autoimmune diseases and our goal is ♠★↔to minimize the burden of disease. Lilly is i↓♣™±nvesting in leading-∑ $edge clinical approaches across our iβ↑ mmunology portfolio in hope↑§s of transforming the autoimm≥₽→une disease treatment experience. We've bui£ ¶±lt a deep pipeline and ÷↕are focused on advancing cutting eππδdge science to find new treatments that offer m₹✔ ♦eaningful improvements t÷γ€o support the people and tε£he communities we serve.Ab €out Eli Lilly and CompanyLilly↑₩₽ is a global health care leader that unites£♥ caring with discoverφ±y to create medicines that make li ÷ ↔fe better for people aroun↓$★d the world. We were founded more  σ÷©than a century ago by a man commit•≠ted to creating high-quality medic‍×ines that meet real needs, and today we remain tr&→ue to that mission in all‌✘✘ our work. Across the globe, Lilly employ∞★♣ees work to discover and bring life-αα‍βchanging medicines to those who need them, impr∑¥★ove the understanding and management of diseas✘↓♣e, and give back to ♠<‍∑communities through philan≠σthropy and volunteerism. To learn more♠≠₽ about Lilly, please visit us at lilly.com and ≤αlilly.com/newsroom. ε✘∞≥ P-LLYThis press release contai↔β‍ns forward-looking statements (as that term is  ♠αdefined in the Private Securities Litigat✔↕♦ion Reform Act of 1995) about Taltz (ixekiz ÷™$umab) as a treatment for ankylosing sp♠♦ondylitis, and reflects Lilly's current  ≠belief. However, as with φ₩any pharmaceutical product, there <∞‍ are substantial risks and uncertainties in the£& process of development and commercializati$‌σαon. Among other things, there c∞₽an be no guarantee that Taltz wiε×ll receive additional regulatory approval∏✔ δs or be commercially successful. For furth✔ ₩er discussion of these and other risks and u ₽<∑ncertainties, see Lilly's most recent Form 10-K↑$ ↔ and Form 10-Q filings with the≠' United States Securit₽♥ ®ies and Exchange Commission. Except a∞←<♦s required by law, Lilly undertakes no$φ duty to update forward&γ¶↔-looking statements to reflect even≤‌§§ts after the date of this release. ↑PP-IX-US-2795 08/2019 © Lilly USA, LLC 20↔λ÷ 19. All rights reserved.₩₩Ω₽ Taltz® is a registered trademark ow€₩&₩ned or licensed by Eli Lilly and Com δ☆pany, its subsidiaries, or affil∞÷iates.from pharma focus aisathe 2019 Asia-p±¥≈₽acific Pharmaceutical IP Leader☆∑ Summit will be held in B★δ$eijing on November 1σ®€←4-15, and will attract more than 500 industry ex§'≤αperts from domestic and foreign δ ↑★pharmaceutical companies, biotechnology coβ♣mpanies, governments,&§↑ associations, law firms, intell≠<↓γectual property agents and other companies to a¶←>ttend.Official registratio♦ ‍​n and consultation channels:Contact：AnnPhone: 021♥$•$-65650305Email：Marketing@zenseegroup.comhttp:/§∞∏/en.zenseegroup.com/p/510934/