Eli Lilly and Company announc¶∏✘γed today that the U.S. Food and Drug Admini<∞≤stration (FDA) has approved Taltz® (₽∞$ ixekizumab) injection 80 mg/mL for the ≥≤&treatment of adults with active ankylosing spo× ∞♥ndylitis (AS), also known as radiographic axial '₽• spondyloarthritis (r-axSpA).This is the third ε→βindication for Taltz, which was first approv¥≤σ ed by the FDA in March 2016 α↕♥∞for the treatment of moderate to seve→‌re plaque psoriasis in adult ≠™patients who are candidates for systemiπ∞c therapy or phototherapy and ±®then approved by the FDA in December 2017 f¶≥←or the treatment of adults with active psoriatiσ¶≈>c arthritis."Ankylosing spondyliti¥Ωs is a challenging disease t§↔<πhat can cause severe back pain and if left unt€‍≠reated, can significa★π•ntly impact patient mobility," said¶' ≥ Rebecca Morison, vice president↓​λ§, U.S. Immunology at Lilly. "We are excited &♥to now offer Taltz as a treat≤∏ ment option for people in need of reli$★✘ef from the symptoms of AS. This approval fu®✔rther underscores Lilly's¥€≤γ commitment to helping people living with rheumat↓εic diseases."Taltz may be administe&δred alone or in combπ$​≤ination with a conventional disease-modify₩ ing antirheumatic drug (e.g. sulfasalazine), cort€Ω¶$icosteroids, non-steroidal anti-inflammatσλory drugs (NSAIDs) andλ≠≤‍/or analgesics. Taltz should not be used in patieαδnts with a previous se←↓rious hypersensitivity, such©≤ as anaphylaxis, to ®★≤ixekizumab or to any of ←₩§the excipients. Taltz m"£ay increase the risk of infecti↔™on. Other warnings and precautions for Taltz incλ♦lude pre-treatment evaluation for tu∑↓§♣berculosis, hypersensitivity∑♦  , inflammatory bowel dis↔•ease, and immunizations. See Im®★✔portant Safety Information below.AS is a typ£↕β↑e of spondyloarthritis that aff¶ εβects the pelvic join₹€ts and spine, and can be characterized by chro₩$α∑nic inflammatory back p✔ ain, stiffness and impai≈δ$red function and mobility.™βσ 1 AS is estimated to impact approximately 1.6 mi€☆αllion people in the U.S.2"Havin×÷¶ g new treatment options for ≈↔β←the ankylosing spondylitλ is community is truly encouraging," said Cas≈σ≠sie Shafer, chief executive offi∑φ✘$cer of the Spondylitis Association o☆∞f America. "The ongoin&•¥g focus to help people impacted by the >♠​disease will hopefully lead us to an ev↑≈entual cure."The efficacy an÷>♣™d safety of Taltz in AS was demonstrated in two© ♦✔ randomized, double-blind, placebo-controlled ​✔δPhase 3 studies that included 657 adult p®↑ atients with active AS: ±∏COAST-V in patients who are biol∞∑φogic disease-modifying a'∞ntirheumatic drug (bDMARD)-naïve and COAST-W in≈¶λ↓ patients who previously haλ•d an inadequate response or were iεε'≤ntolerant to tumor necrosis factor (TNF) inhibi≥Ω'πtors.In both studies, the prima£α±ry efficacy endpoint was the₹φ→ proportion of patients at 16 weeks achievin¥<g Assessment of Spondyloartλ÷₹hritis International Society 40 (ASAS40) respon✘♥σse compared to placebo. ASAS40 measures÷"☆÷ disease signs and symptoms such as pain,≠™ inflammation and function. The COλ© ♥AST clinical trial program includes the fi€Ω♣rst and only registration trials in AS to"​¥ achieve ASAS40 response at 16 weeks as a prim≠§ary endpoint. Results from both ↑∞"studies demonstrated that patients treated≠×₹✘ with Taltz achieved statistically sig ∞¥nificant and clinically meaningful improvem ₩•♥ents in signs and symptoms, as defin✔♠ed by ASAS40 response, compλ∏∏ared to placebo. At 16 weeks, patients ¥α♦ achieved ASAS40 at the foll≠•owing response rates:COAST-V♣♥¥™: 48 percent of patients t☆∑ reated with Taltz every four weeks versus 18♣× percent of patients treated with placebo (p<↔™÷;0.0001)COAST-W: 25 percent of ✔π ✘patients treated with Talt∑©≥z every four weeks versus 13 percent of ✘&← patients treated with pπ>★lacebo (p<0.05)Additionally, patients trea₹φted with Taltz demonstrated statistical "βly significant improvements in key se&λ←©condary endpoints in bot÷★β♠h studies, including the proportion of patien∞>ts at 16 weeks achieving ASAS20 at the follow×€ing response rates:COAST-V: 64 €±percent of patients treated with TΩ₽₩ altz every four weeks versus 40 percent of pa≤£tients treated with placebo (p=0.0015)COAST-W: 4ε±‌☆8 percent of patients treated wit'★$h Taltz every four weeks versus 30 percent of pat♥φients treated with placebo (p<0.01)Overa$πγ€ll, the safety profile observed ∏$εin patients with AS treated¥ "÷ with Taltz is consistent with t©π‍he safety profile in patients wit≤✘♦'h psoriasis."Results from the Ph≈λase 3 clinical trial program in ankylosing spo→×≤ndylitis show that Taltz helped r>≥§ educe pain and inflamma↕α"tion and improve function in patients who hadΩ≥∑✘ never been treated w¥∑‌ith a bDMARD as well as those who previously £¶failed TNF inhibitors," said Phili♥¥§γp Mease, M.D., Swedish Medical Center/Provi<↓±dence St. Joseph Health and Universi©€ ty of Washington. "This approval is an impor♠ tant milestone for patients and physi♣ cians who are lookin®©♣g for a much-needed alteα¶♥βrnative to address symptoms €∞$of AS."Lilly will workσ✘ with insurers, health s₹₩ystems and providers÷↔ to ensure patients are able to∏  access this treatment. Patients, physicians,¥←→↔ pharmacists or other healthcare profββ₩↔essionals with questions about ↔≈Taltz should contact The Lilly Answers§‍± Center at 1-800-Lilly↕•Rx (1-800-545-5979) or visit www.lilly.co↑↕m.IndicationsTaltz is appro<₩ved for the treatment of adults wiπ♥♣th active ankylosing spondylitis. Taltz iγ♣¶s also approved for the treatmenβ<♥↓t of adults with active psoriatic arthritis and δ♦adults with moderate to severλ↓↔±e plaque psoriasis who are candidates for syste♠•÷mic therapy or phototherapy.IMP‍✘←ORTANT SAFETY INFORMATIONCONTRAINDICATIONSTalt↓☆δz is contraindicated in patients wit★↔δh a previous serious hypersensiti©♥γ vity reaction, such as anaphylaxis, 'αto ixekizumab or to any of the excipien$≥ts.WARNINGS AND PRECAUTIONSInfectionsTaltz λε↕<may increase the risk of infection. ™₹λIn clinical trials of patients wiφ εth plaque psoriasis, the Talt♦★♥ z group had a higher rate of infec×​σ$tions than the placebo gr♣βoup (27% vs 23%). A simila™♠r increase in risk of infection was seen i ↑ <n placebo-controlled trials of patie ‌σβnts with psoriatic arthritis and ankylosing £λspondylitis. Serious inf∑∑‌ections have occurred. Instruct patients to ± seek medical advice if sign♠₽s or symptoms of clin‍βically important chronic or ↑↑acute infection occur. If a se♠↔εεrious infection develops®≤✔, discontinue Taltz until the infection reso∑πlves.Pre-Treatment Evaluation for Tu↓♠¥berculosisEvaluate patients for tuberculosi♣ε←s (TB) infection prior to ini"∞tiating treatment wi$β§th Taltz. Do not administer to patients with→★≤> active TB infection. Ini©β₹™tiate treatment of latent T±β¶B prior to administering Taltz. Closely‌φ monitor patients receiving Taltz for signs and•"÷↑ symptoms of active TB ®♦∞©during and after trea®☆↓™tment.HypersensitivitySerious hypersensitivityσ¥ reactions, including angi≠'↓oedema and urticaria (each ≤0.1%), occφ✔​±urred in the Taltz group in ☆×φ"clinical trials. Anaphylaxis, in'♦cluding cases leading to hospitalization, < γ€has been reported in post-marketing use wit≤¶®h Taltz. If a seriou≥ε∏s hypersensitivity reaction occ≠'‍®urs, discontinue Taltz immedγΩ•iately and initiate appropriate th"≠®γerapy.Inflammatory Bowel Disea∏÷✔seDuring Taltz treatment, monitor patients for <$onset or exacerbations of infl€‍ammatory bowel disease. Crohn↕​↓'s disease and ulcerative colitis♦α→, including exacerbations, occurred ÷✔§at a greater frequency in the×↔♦‍ Taltz 80 mg Q2W group (Cr ®ohn's disease 0.1%, ulcerative coli "tis 0.2%) than in the placebo group (0%) during c•€÷≥linical trials in patients with plaque psor≥₩>≥iasis and in the Taltz Q4W group in ankylo✔>©sing spondylitis trials (Crohn's§β disease 1.0% [2 patients], ulcerativ±€♦®e colitis 0.5% [1 patient]) th§™₹an in the placebo group (Crohn'γ✔£<s disease 0.5% [1 pa£≤•tient], ulcerative co÷≥∑litis 0%). In the ankylos<™ing spondylitis tria¥₹ls, serious events occurred in 1 patient in t&÷₽₽he Taltz group and 1 patient ‍↓§in the placebo group.ImmunizationsPrior to i♦↕"₩nitiating therapy with Taltz, consider c ₩Ωπompletion of all age-appropriate immunization∞ €s according to current £€immunization guidelines. Avoid use of <→<live vaccines in patients treated wi♠ λεth Taltz.ADVERSE REACTIONSMost common adverse reaβ↓ctions (≥1%) associated w♣γ€ith Taltz treatment are inj♦♦ection site reactions, upper respiratory tract i♦✔nfections, nausea, and tin​‍‍πea infections. Overall, th♥"<e safety profiles observed in patients with pφ♦←'soriatic arthritis and ankylosing spondylitiγ✘<s were consistent with the safety profile in ​>patients with plaque p£<↔soriasis, with the exception of influenza and "β conjunctivitis in psoriatic arthritα≤≤is.Please see full Pre₩♠scribing Information and Medication Guide for ₽¶₹Taltz. See Instructions for Use included with t←​he device.IX HCP ISI 23AUG2019About Taltz®Taltz® ®®(ixekizumab) is a moγδnoclonal antibody that se₩§$αlectively binds with in'∑©<terleukin 17A (IL-17A) cytσ÷ ₩okine and inhibits its interaction‌♦® with the IL-17 receptor. IL-17A is ‍'a naturally occurring cytokine that₽≈ is involved in normal inflammatorε★​&y and immune responses. Taltz inhibits the ✔‌₽release of pro-inflammatory c<∑>ytokines and chemokines.A↓✘←bout Lilly in ImmunologyLilly is bringing × our heritage of championing groundbreaking, φ>↑←novel science to immunology and is dri'→ ven to change what's possible for∑×₽φ people living with autoimmune diseas✘↕εes. There are still significant unm ✔™≠et needs, as well as personal and sβ↕$αocietal costs, for people living♣≤ with a variety of autoimmuλ↑​₽ne diseases and our goal is t‌σ o minimize the burden of disease. •γ∑≤Lilly is investing in®λδ leading-edge clinical approaches §•across our immunology portfolio in hopes of tra™ ™nsforming the autoimmune dise€¥↓ase treatment experienc≤©e. We've built a deep pipeline a∏‌‍nd are focused on adv≥♣ancing cutting edge science to find new tr₹πeatments that offer meaningful improvements t≈ ↑≈o support the people aδ÷©nd the communities we serve.About Eli Li&±σ©lly and CompanyLilly is a global h≥ αealth care leader that u•✔nites caring with disc£←overy to create medicines that γ≈make life better for people around theΩ±÷ world. We were founded more than a ←↓ century ago by a man committed to ₩"αcreating high-quality medicines that meet‍αΩ∑ real needs, and today w€>εe remain true to that mission in™§ all our work. Across ♠₩the globe, Lilly employees work♥↔♦☆ to discover and bring >♠↕life-changing medicines to those who >¥↓need them, improve the understanding and m$✘anagement of disease, and give back to communit&≥₹ies through philanthropy and volunteerism₹÷. To learn more about Lilly, please₩↓ visit us at lilly.com and lilly.com/newsroom.&nbΩγ ‍sp; P-LLYThis press release contains forwar★®↑↑d-looking statements (as that term₹↕ is defined in the Private Securit♦δ"ies Litigation Reform Act of 1995)σ×‍‌ about Taltz (ixekizumab) as a treatment fo ≥φ‌r ankylosing spondylitis, and reflects Lilly's £≠★current belief. However, as with any∞§<£ pharmaceutical product, there ★₽δ↕are substantial risks and uncertainties in the pr™↑ocess of development and commercializaδ>‌tion. Among other things, there can be no guara♦<β∑ntee that Taltz will receive additional reg∑σ&ulatory approvals or be co✔¶ mmercially successful. For further discussion o≥×∞f these and other risks and unc<> ×ertainties, see Lilly's most recent Form $♠←10-K and Form 10-Q filings with t↑φ∞he United States Securiπ∑ties and Exchange Commission. Except←δ≠ as required by law, Lilly under♣±takes no duty to update forward-looking  ∏statements to reflect events after the dat®♥♦e of this release.PP-IX-US-2795 08/'↕2019 © Lilly USA, LLC 2019.₽δ♥  All rights reserved. Taltz® ε§γis a registered trademark owned or licensed by>‍‍∞ Eli Lilly and Company, its subsidiaries, orδ  affiliates.from pharma focus aisathe&₹✔✔®nbsp;2019 Asia-pacific Pharmaceutical IP §π↔Leader Summit will be held in'γ€γ Beijing on Novemb↑δ☆♠er 14-15, and will attract more thγ≠φ↕an 500 industry experts from dome★$÷↓stic and foreign pha✘©rmaceutical companies, '→¥biotechnology companie™♣≥s, governments, associations, law firms, intelle₹ ™÷ctual property agents and other companie✘¶™→s to attend.Official registration and consultaβ©δ•tion channels:Contact：AnnPhone: β$φ021-65650305Email：Marketing@ze<↕‌←nseegroup.comhttp://en.zenseegro→≤up.com/p/510934/