Eli Lilly and Company ₹ →announced today that the U←'←.S. Food and Drug Administration (FDA) ha​&€≥s approved Taltz® (ix∑♠ekizumab) injection 80 mg/mL for the tre→≥atment of adults with active ankylosing s∑₽ ↓pondylitis (AS), also known as radiog©< raphic axial spondylo✘♦♠≤arthritis (r-axSpA).This is  €₽the third indication for T₹™altz, which was first approved by the ★γ↓♠FDA in March 2016 for the treatment of moder÷↕↓♦ate to severe plaque psoriasis>£σ in adult patients who are ​γ¶ candidates for systemic therapy or phot₹≈£otherapy and then approvedα× by the FDA in Decemb<→er 2017 for the treatment of adul£$ ts with active psoriatic arthritis."Ankylosing s‌‍≥pondylitis is a challenging disease that can ca ♣use severe back pain and if left untre£®₩÷ated, can significantly impact patient mo$​bility," said Rebecca Morison, vi↓¶♦ce president, U.S. Immunol‍₩₽♠ogy at Lilly. "We are excited to ÷<εγnow offer Taltz as a treatment option for peopl✘×‍e in need of relief from αγthe symptoms of AS. Th↕∞✘¶is approval further u✔λnderscores Lilly's commitment$" to helping people living with rheumaσε<tic diseases."Taltz may ✘'be administered alone or in combinatioπ★±πn with a conventional di₩×sease-modifying antirheumat&∏ic drug (e.g. sulfasalazine), corticosteroidsε₽λ, non-steroidal anti-inflammatory dru÷≠gs (NSAIDs) and/or analgesics. Taltz s‌πhould not be used in patients wit ∑↓h a previous serious hype"σ©​rsensitivity, such as anaphylaxis, to β≤ixekizumab or to any of the excipients. Taltz m"☆∑"ay increase the risk of infection. Other warnings​β and precautions for Taltz inφ¶clude pre-treatment evaluat←§ion for tuberculosis✔¶✘∏, hypersensitivity, inflammatory bowel disease, ≥<and immunizations. See Important π≈✘Safety Information below.AS is a type of ↔≥₹spondyloarthritis that affects the pelvic≠§♥φ joints and spine, and can be &✘∑✘characterized by chronic inflammatory ba‍<↑ck pain, stiffness and impaired function a≠♦₽≥nd mobility.1 AS is estimated to impact approximδ★π₩ately 1.6 million peopl∏↔ e in the U.S.2"Having new treatm γent options for the ankyl >osing spondylitis commun÷∞σity is truly encouraging," sai✔'d Cassie Shafer, chief executive officer of "₹‌ the Spondylitis Association of Ameri ♠ca. "The ongoing focus to help peopl✘‍♥e impacted by the disease "&πwill hopefully lead us to an eventual cure."The✘ ♣ efficacy and safety of Talt≠‍☆∑z in AS was demonstrated in two rando"πΩmized, double-blind, placebo-controll®"↔₽ed Phase 3 studies that included 657 adult patienα≥ts with active AS: COAST-V ≠$₹in patients who are biologic"¶ disease-modifying antirheuσ±<$matic drug (bDMARD)-n‌£aïve and COAST-W in patients who previously had σ≠™↑an inadequate response or were intoler♠§≈←ant to tumor necrosis factor (TNF) inhibito₽<≥rs.In both studies, ∞‍₩≠the primary efficacy endpoint was the proporti&ε₩on of patients at 16 w←¥↔γeeks achieving Assessment of Spondyloarthr±✔£itis International Society 40 (ASAS40) r¥​★↔esponse compared to placebo. ASAS40 mea‍<sures disease signs and symptoms such as pain, in"©γ'flammation and function. The COAST c♠☆®linical trial program includes the first and Ω only registration trials in AS to ac☆>hieve ASAS40 response at 16 weeks as a prim←↓↑‍ary endpoint. Results from both studies dem™∏ ★onstrated that patients treated with Taltz achie£©♣ved statistically significant and cl☆↔inically meaningful impro≠♣vements in signs and sympto≥≈"£ms, as defined by ASAS40 response, <≈•₩compared to placebo. Atσ♣™ 16 weeks, patients achieved ASAβ&§£S40 at the following response rates:COAST-V:  ♦✔♦48 percent of patients treated γ®αwith Taltz every four weeks ver​×"sus 18 percent of patients ♠♦  treated with placebo (p<0.0001)COAST-™×♥≥W: 25 percent of patients treated with Taltε♠z every four weeks vers↔γσus 13 percent of patients treaγ↓★ted with placebo (p<0.05)Addit₽>ionally, patients treated with↕£↔< Taltz demonstrated statistically significan₹↔t improvements in key✔±< secondary endpoints in both studies, includi≤¥ε‍ng the proportion ofα Ω patients at 16 weeks‌©δ achieving ASAS20 at the followi'©‌ng response rates:COAST-V: 64 percent of pati∞γ™ents treated with Taltz every four weeks versu&αs 40 percent of patients treated βπ with placebo (p=0.001☆↓ε£5)COAST-W: 48 percent ™π♦£of patients treated with Taltz every four weeks☆→ versus 30 percent of patients treated with place¥β♦₽bo (p<0.01)Overall, the safety profile observe↑₹☆d in patients with AS treated with Taσ£ltz is consistent with the safety profile in≠<σ≈ patients with psoriasis."Results from theγ  Phase 3 clinical trial program in ankylosing δδspondylitis show that Taltz helped reduce λ©©₽pain and inflammation and improve functio♦σ↓♣n in patients who had never b₩±een treated with a bDMARD as well $±¶→as those who previously failed TN©®F inhibitors," said Philip ←≤®Mease, M.D., Swedish MedΩ✘ical Center/Providence St. Josep≈☆h Health and University of Wash♠δ↔ington. "This approval is an i γ☆‌mportant milestone for patients and physi♥$∏§cians who are looking for a much-ne&♦•eded alternative to addres÷αs symptoms of AS."Lilly will work w÷™♥$ith insurers, health systems and providers to ens☆εure patients are able to aε★ ★ccess this treatment. Patients, phy$π sicians, pharmacists or o​δ★←ther healthcare professionals with  ±↔‌questions about Taltz should contact The Lilly A¶γ←♠nswers Center at 1-800-LillyRx (1-800-545-5979) o✔>≥£r visit www.lilly.com.Indica↑λ'↓tionsTaltz is approved for the treatment↓≈¥π of adults with active an'α≠kylosing spondylitis. T¥∞∑σaltz is also approved•☆ for the treatment of adults with acti©€ve psoriatic arthritis ✘÷¶and adults with moderate to severe plaque psoriasΩ∑δαis who are candidates for systemic ther≠¥≥apy or phototherapy.IMPORT‍ δ¥ANT SAFETY INFORMATIONCONβ☆∑γTRAINDICATIONSTaltz is contraindicated in patie"↑∑•nts with a previous seriou$☆★s hypersensitivity reaction, such as anaph​§←φylaxis, to ixekizumab or to any of the excipien∏β↑ts.WARNINGS AND PRECAUTIONSInfectionsTal>Ω∏εtz may increase the risk oδ f infection. In clinical trials ♣σ↕'of patients with plaqu​☆e psoriasis, the Taltz gro♥≥up had a higher rate of infection ∏♥s than the placebo group (27% vs 23%). A si♦<​milar increase in ris∏α←k of infection was seen in placeb ¶o-controlled trials of patients with psoπ$$riatic arthritis and ankylosing spondylitis. Seφ'€πrious infections have occurred. δ≈₩Instruct patients to s↑©♣eek medical advice if signs or symptoms♠↕λ of clinically important chron£↕πic or acute infection occur. If a seriou™‍ ↓s infection develops, dis↔ ♠≈continue Taltz until the infection resol✔↓ves.Pre-Treatment Evaluation for Tube$≤rculosisEvaluate patients for tuberculosis (TB§ <) infection prior to initiating treatment with →≥∑‍Taltz. Do not administer to patien≤®₩ts with active TB infection$δ✘. Initiate treatment of latent TB prior ✔&¶γto administering Taltz. Closely monitor p§ε₩"atients receiving Taltz f®φ☆​or signs and symptoms of act∑¥©♠ive TB during and after treatment.§™HypersensitivitySerious hypersens©ε∞itivity reactions, including angioedem→‍a and urticaria (each ≤0.1•§π₩%), occurred in the Taltz group in clinical₽ ∏♦ trials. Anaphylaxis, including case >♥s leading to hospitalization,✔♠≥ has been reported in∏¥δ post-marketing use with Taltz. If a ser≤∞δious hypersensitivity reaction occβ₩'urs, discontinue Taltz immediately and ♠‌""initiate appropriate therapy.Inflammatory Bowel™★> DiseaseDuring Taltz treatment, monitor patien∏‌σδts for onset or exacerbations π∏∑of inflammatory bowel disease. Cr™ ★ohn's disease and ulcerative colitis, i≤♦→σncluding exacerbations, occurred at a greater fr∑₽equency in the Taltz 80 mg Q2W group ≠¶>÷(Crohn's disease 0.1%, ulcerativeλ★☆​ colitis 0.2%) than in the placebo group (0%) d "∏≈uring clinical trials ‌•in patients with plaque psoriasis and in the α Taltz Q4W group in ankylosing spondyl₽"ε​itis trials (Crohn's disease 1.0% [2 pati•÷•ents], ulcerative colitis 0.5% [1 patie®&☆nt]) than in the placebo grou♥₹☆p (Crohn's disease 0.5% [1 patient], ulcera∞ ÷​tive colitis 0%). In the ank₹'ylosing spondylitis trials, se€Ω≥‌rious events occurred in 1 patient in the↔∞ Taltz group and 1 patient in the pε✘♠lacebo group.ImmunizationsPrior to initiating th‍£Ω÷erapy with Taltz, consideλπ¶✔r completion of all age-appropriate immunizat♦±ions according to current im₹φδ munization guidelines. Avoi↑← d use of live vaccines in pat₽​♦↔ients treated with Taltz.ADV‍&δERSE REACTIONSMost common adverse re•>∞actions (≥1%) associa±✘φted with Taltz treatment are injection s γite reactions, upper respirator δy tract infections, nausea, and tinea infβ ​Ωections. Overall, th∞¶ e safety profiles observed in patienβ₽∞​ts with psoriatic arthritis and ankylosing α↔ spondylitis were consisα£tent with the safety profile in patient ≤→→s with plaque psoriasi∑ <‍s, with the exception of influ&•enza and conjunctivitis in psoriat ¥ic arthritis.Please sα↔≠←ee full Prescribing Information©≈↕ and Medication Guide for Taltz. Se★ $e Instructions for Use in∞∑cluded with the device.IX HCP ISI§  23AUG2019About Taltz®Taltz® (ixeki±¥α≠zumab) is a monoclonal antibody that sele♥£$↕ctively binds with i<& nterleukin 17A (IL-17A) cytokine and i"∞≤γnhibits its interaction with the ↕&IL-17 receptor. IL-17A is a natu↓✘&rally occurring cytokine that is involved in§≤• normal inflammatory ←ελ≤and immune responses. Tal≥$→tz inhibits the rele¥Ω£ase of pro-inflammator♦ ♥y cytokines and chemokines.≠‌About Lilly in ImmunologyL÷‌illy is bringing our heritage of championing g₩≈φroundbreaking, novel scien'‍ε&ce to immunology and is driven to ch∑₹₹₩ange what's possible fo<↓r people living with autoimmune diseases.¶‍ ε There are still significant unmet needs, a÷∞s well as personal and soc‌↔π ietal costs, for people living with§>‌π a variety of autoimmune diseases and our goal↔®↕↑ is to minimize the bur©&×↓den of disease. Lilly is  ↓ investing in leading-edge clini♣πcal approaches across our φ∑✘∑immunology portfolio in ±•♦£hopes of transforming the autoimmune disease tr•←''eatment experience. We'v∏×e built a deep pipeline a↑≤nd are focused on advanc‌>ing cutting edge science to find new trea€♦tments that offer meaningful improvementφ≥s to support the people and the communities♥& we serve.About Eli Lilly and CompanyLi÷‌ ↔lly is a global healt∑€★h care leader that unites caring with discovery ε←to create medicines that make life be₹₽§∏tter for people around the worl♥<☆d. We were founded more than ε∞‍'a century ago by a maλ£πn committed to creating high-q≠♠uality medicines that meet real needs, a₹©₹nd today we remain true to that mission in∏‍←₽ all our work. Across the globe, Lilly ±​£≠employees work to discover a£'nd bring life-changing medicines to those who"φ need them, improve the understanding and manag♥ δ∏ement of disease, and  ✘☆©give back to communities through philanthropy ¶₩₩and volunteerism. To learn more abΩ₽ ™out Lilly, please visit us at lilly€'.com and lilly.com/newsroom.  P-LLYThis pres✔Ωs release contains forward-lookin​÷g statements (as that ¥≤&€term is defined in the Private Securities ∞¥‍Litigation Reform Act of 1995) about §♥↕Taltz (ixekizumab) as a treatm ±ent for ankylosing spondylitis, and refle÷ ±cts Lilly's current belief. Howeverλ$, as with any pharmaδ↑•ceutical product, ther>♦☆e are substantial risks and uncertai∑∏•nties in the process of development and co×σ§ mmercialization. Among other things™σδ, there can be no guarantee that Tal™'≈tz will receive additional€≥✘≤ regulatory approvals or be commercially success'≈↑ful. For further discussion of↓ε these and other risks a‍≠α>nd uncertainties, see Lilly'™≈©s most recent Form 10-K and Form 10-Q ₽≤&★filings with the United States Securities and E€β xchange Commission. E εxcept as required by↓∞¶  law, Lilly undertakes no duty to →←update forward-looking st£÷☆atements to reflect events af<λter the date of this release.PP-IX-US-2795 08/<∞2019 © Lilly USA, LLC 2019. All ri±γ€"ghts reserved. Taltz® is a registered trademar♦​☆>k owned or licensed by Eli Lilly and∑€✔¶ Company, its subsidiaries, or affiliates.☆φ​∞from pharma focus aisathe 2019 Asia-pacific₽>< Pharmaceutical IP Leader Summit&n→♥ bsp;will be held in γ≈§&Beijing on November 14-15, and •₩±₽will attract more than 500 indu↑↕stry experts from domestic and foreign pharmace₩ ↑↑utical companies, biotechnology cε☆↑Ωompanies, governments, associations, law firms★$", intellectual property agentβ←£&s and other companies to attend.Official r ↓egistration and consultation channels:Contact：≥<AnnPhone: 021-65650305E¥∑→mail：Marketing@zenseegroup∑≤₹φ.comhttp://en.zenseegroup.com/p/510934/