Eli Lilly and Company announced today that the U←✘δ.S. Food and Drug Administ↕↔"ration (FDA) has approved Taltz® (ixekiz♦β₹umab) injection 80 mg/mL for the t≤σreatment of adults w♣₽ith active ankylosing spondylitis (AS)¥♠, also known as radiographic axial s£♠pondyloarthritis (r-axSp™‍¶ΩA).This is the third indication for ±↕≥Taltz, which was first approved by the FDA →✘₩in March 2016 for the treatment of moderate← Ω​ to severe plaque psoriasis in ♥<♦→adult patients who are candidate✔∏s for systemic therapy or pho≤εtotherapy and then approved by the FDA in Dec →→ember 2017 for the treatment of adults with a€≤•ctive psoriatic arth£♣•↓ritis."Ankylosing spondylitis is a©★ challenging disease that can cau$™se severe back pain and if left untreated, can​§σ♠ significantly impact patient mobi©™lity," said Rebecca Morison, vice p↔♥∏resident, U.S. Immunology at Lilly. "We are excit"‍λ<ed to now offer Taltz as a treatment option for p×®eople in need of relief fr¶&om the symptoms of AS. This approval f≥®urther underscores Lil↕← ≤ly's commitment to helping people liv↕✘ ₽ing with rheumatic diseases."Taltz may be adm≈∏®>inistered alone or in combinati≥®on with a conventional disease-modifying antirπ<←φheumatic drug (e.g. sulfasala≠πzine), corticosteroi∏ ds, non-steroidal anti-inflammatory drugs (NSA→≥αIDs) and/or analgesics©&<. Taltz should not be used i∏∑n patients with a previous serious hypersensiti♠≠∏vity, such as anaphylaxis, to ixekizumab or to an&π ☆y of the excipients. Taltz may increase t₩₽±he risk of infection. Other warn₩‍↕ings and precautions for Taltz include prφ¥×e-treatment evaluation for tuberculosis, hy↓εδ£persensitivity, inflammator₹☆✔≤y bowel disease, and immunizations. Se£✔∏e Important Safety Information ♥↕♠below.AS is a type of spondyloarthritis ←↓φthat affects the pelvic joint §©§s and spine, and can be ©¥characterized by chr∑≠↓onic inflammatory ba∑★♦ck pain, stiffness and impaired function anπ™< d mobility.1 AS is estimated tφ©'•o impact approximately ♠Ω 1.6 million people in the U.S.2"Having new ₹≠₽‍treatment options for the ankylosin♠>≈g spondylitis commun &α↓ity is truly encourag''™ing," said Cassie Shafer, chief executive off££♦‍icer of the Spondylitis Association of Americ>≥λa. "The ongoing focus to help people impacteλ≥≤£d by the disease will hopefully lead us∞© to an eventual cure."Theγ★✘" efficacy and safety of Taltz in A×≥λS was demonstrated in t★←®wo randomized, double β-blind, placebo-controlled Phase 3 st♣ ©≠udies that included 657 ad§↕ult patients with active AS: COAST-V in pat≤<↕★ients who are biologic disease-modifyin© ₹g antirheumatic drug (bDMARD)-naïve and COAST-&&αW in patients who prev☆₩$¥iously had an inadequ≈•★≈ate response or were intolerant to tumor necφ‌$rosis factor (TNF) inhibitors.In both stud♦←→ ies, the primary efficacy endpoint was t← <he proportion of patients at 1₩♠ ₩6 weeks achieving Assessment of  δ₹Spondyloarthritis International ↔≥≈♦Society 40 (ASAS40) resp↔₹©onse compared to placebo. ASAS40 mea &©×sures disease signs and symptoms such a★βs pain, inflammation and≈ε function. The COAST clinical trial program​₽&≈ includes the first a₹¥ nd only registration trials in AS to achieve ASAβ↕S40 response at 16 weeks as a ≤↓ ¶primary endpoint. Results from both s ‌♣↔tudies demonstrated ↓​γ¶that patients treated with Taltz achieved >✘ ↔statistically significant and clinically meani♦×ngful improvements in signs and symptoms, as de¶£♠∞fined by ASAS40 response, compared to↑£​→ placebo. At 16 weeks, pat<™ients achieved ASAS40>γβ' at the following response rates:CO€♦↓÷AST-V: 48 percent of patients treated withλ ¶® Taltz every four weeks versus 18 percent o§←βf patients treated with placebo (★→p<0.0001)COAST-W: 25 percent™≤δΩ of patients treated w>♦ ith Taltz every four weeks versus 13 perc ₩<♣ent of patients treated with placebo (p<0.0&λ5)Additionally, patients treated withש Taltz demonstrated statistically ♥×®significant improvements in key seconσ÷§dary endpoints in both studies, including the≠✘ proportion of patients at 16 weeks ac γ hieving ASAS20 at the following response rates:♠ δCOAST-V: 64 percent of patients treat∑¶✘φed with Taltz every four weeks versus 40 pe↔₽​‌rcent of patients treat♠₩ed with placebo (p=0.0015)COAST-W: 48 perce£®≥σnt of patients treated with Taltz ≈£∞φevery four weeks versus 30 percent of patienα∞¥ts treated with placebo (p&€<$♠lt;0.01)Overall, the safety profile ob♦≥"served in patients with AS treated wit≥"h Taltz is consistent with the safety profil™≈∑®e in patients with psorias‌∑↓≤is."Results from the Phase 3>™αβ clinical trial program in ankylosing spondyliti$←£÷s show that Taltz helped reduce pain and inflammδ∞‌₽ation and improve function in pφ≈atients who had never₽ ♥  been treated with a>÷ bDMARD as well as those who previously ¥₽♠failed TNF inhibitors," said Ph★₹↓ilip Mease, M.D., Swedish Medical Center/P÷↔rovidence St. Joseph Health and Univ£↔×✘ersity of Washington. "Th↕λ★is approval is an imp≈δαΩortant milestone for pati✘λ∞ents and physicians who are look←★ing for a much-neededσ•δ alternative to address symptoms of AS."Lillγ↔§y will work with insurers, health systems and ↕¶‍providers to ensure patien∑≈✘↔ts are able to access this treatment. Patient↔πs, physicians, pharmacists or other ∑✔♦healthcare professionals with qu"≥estions about Taltz should contact The Lilly↑≤>' Answers Center at 1-800-LillyRx (1σ→φ≠-800-545-5979) or visit www.lilly.c←∏σom.IndicationsTaltz is approved for the treatα  €ment of adults with acti••♣ve ankylosing spondylitis. Taltz is also apprβφ$§oved for the treatment of adu∏ ≤lts with active psoriatic arthri↕<≥tis and adults with moderate to severe plaqu"​e psoriasis who are candidates for systemic ther¶∏apy or phototherapy.IMPORT‌↑₹ANT SAFETY INFORMATIONCONTRAINDICAΩ★TIONSTaltz is contraindicated in pat§✘ients with a previou£'s serious hypersensi→$₩€tivity reaction, such as anaphylaxisλ$, to ixekizumab or to ☆♦any of the excipients.WARNINGS AND PR™→♣ECAUTIONSInfectionsTaltz may increase the ris ©"↔k of infection. In clinical trials ∑✘↑σof patients with plaque•♠‌≥ psoriasis, the Taltz group <γ÷←had a higher rate of infeβ♦ctions than the placebo group (27% v→ε₹s 23%). A similar increase₹φ★ in risk of infection was seen in pl✘≈♦acebo-controlled trials of p≠♠atients with psoriatic arthritis"​♦Ω and ankylosing spondylitis. Serious infecti™ ∏☆ons have occurred. Instruct patients to seek medi≤‍&‍cal advice if signs or symptoms of clinically ★ πimportant chronic or a♥→☆cute infection occur. If a serious  ×↕™infection develops, disconti≠‍nue Taltz until the infection resolves∑‍£§.Pre-Treatment Evaluation f∑↕£ or TuberculosisEvaluate patients for tuberculosis​> (TB) infection prior♠♥ to initiating treatment with Taltz. Do not ad ✘minister to patients with active>™  TB infection. Initiate treatment of latent T‍πβB prior to administering Taltz. Closely✔→σ↓ monitor patients receiving Taltz for signs a₩☆∑nd symptoms of active TB duri• ↑©ng and after treatmen≤₽t.HypersensitivitySerious hypersensiti↔✔♦vity reactions, includiδβng angioedema and ur₽​ticaria (each ≤0.1%), occurred•± in the Taltz group in clinical §÷trials. Anaphylaxis, including cases l€©eading to hospitalization, has been re♠←ε←ported in post-marketing use with Taltz. If a se$>rious hypersensitivity reactiγφon occurs, discontinue Taltz immedia↓↕✘≠tely and initiate appropriate therapy.Inflammatφ★×ory Bowel DiseaseDuring Taltz treatment&£♣, monitor patients for onset or exacerbations of ¥ε£inflammatory bowel disease.¶♠ Crohn's disease and ulcerative ®♣colitis, including exacerbati♥↕∞δons, occurred at a greater frequ♠₽φ ency in the Taltz 80 mg>§ Q2W group (Crohn's dis♠☆¥"ease 0.1%, ulcerative colitis 0.2%) than in the p♣≠‍∞lacebo group (0%) during clinical ÷¥λ∞trials in patients with plaque psor÷♥®​iasis and in the Taltz Q4W group in ankylosing s>☆pondylitis trials (Crohn's disease   §1.0% [2 patients], u≠• ←lcerative colitis 0.5% [1 p§γ'≠atient]) than in the placebo group (Crohn's di ♠sease 0.5% [1 patient], ulcerative∑≈© colitis 0%). In the ankylosing spondyliφ↕tis trials, serious events occurred in 1 patient&> in the Taltz group and 1 pati "₩ent in the placebo group.Immunizat♦¶←♣ionsPrior to initiating ther€ <εapy with Taltz, considφ♥&•er completion of all age-appropriate imm"¥α↑unizations according to current im₩ munization guidelines. Avoid use of live vaccin¥φ±÷es in patients treated with Taltz.ADVERSE REA♣€CTIONSMost common adverse reactions (≥1%) as ®€sociated with Taltz treatment are injection si★✘₹¶te reactions, upper re ∑spiratory tract infections, n§ ¥ausea, and tinea infections. Overall, th∞<>e safety profiles observed in patie ¥←♦nts with psoriatic arthritis and ank↕₹ylosing spondylitis w♠&πere consistent with the safety profile in pa¥<©tients with plaque psoriasis, with the except¶​®ion of influenza and co©→↓±njunctivitis in psori'πatic arthritis.Pleas∑‍₹e see full Prescribing Information and↑σ Medication Guide for Taltz. See In₩™₩≤structions for Use inc≥♠luded with the device.IX β☆HCP ISI 23AUG2019About Talt‍×₩z®Taltz® (ixekizumab)&‌Ω  is a monoclonal antibody that selectively <"binds with interleukin 17A (IL-17A) cytπΩ¥okine and inhibits its interaction with theβ∑ IL-17 receptor. IL-17A is a naturally o∞₽ccurring cytokine that is involved ★δin normal inflammatory and i$π®•mmune responses. Taltz inhibits the rel✔≈≈ease of pro-inflammatory cytokines a→$'♥nd chemokines.About Lilly in ImmunologyLilly i£ ₹s bringing our heritage δβδ$of championing groundbreaking, nov÷<♣el science to immunology and is d≤α riven to change what's possible for¶​ people living with autoimmune disλ•eases. There are still significant unmeε≠t needs, as well as personal and π≥∑societal costs, for people living with a variet₹"₩y of autoimmune diseases and our®¥< goal is to minimize the burden of≠®π disease. Lilly is investing in£• ♠ leading-edge clinical approaches across our im§∑'↔munology portfolio in hopes of tran'φ ₽sforming the autoimmune disease treatment expe♥$ rience. We've built a deσ¶® ep pipeline and are focused o¶♥♥n advancing cutting edg‍→€→e science to find ne ≠$w treatments that offer meaningful improvem®‍  ents to support the peopl≤σ"e and the communities we serve.Abou$₩t Eli Lilly and CompanyLilly is a global he↑φ♦★alth care leader that unites caring with✘¥∞ discovery to create medicines that ma​∏ke life better for people aroασund the world. We were>φ founded more than a ₩∑century ago by a man committed to"  creating high-qualit♠φy medicines that meet real₩≈ needs, and today we remain true   to that mission in all our work. Across the gl↓©€obe, Lilly employees work to discover and bring ♣σ₩life-changing medicines toγ♣∑ those who need them, improve the understan¥ ₩ding and management of disease, and give bac≈‌k to communities through£‌↕ philanthropy and voluntee&δσrism. To learn more about Lilly, please visit u₽$ s at lilly.com and lilly.com/newsro©£↓om.  P-LLYThis pr®​×ess release contains forward-looking s"ΩΩ₹tatements (as that term is defined in the P£☆rivate Securities Litigation Reform Act of 1995 ​→) about Taltz (ixekizumab) as a treatment for ank→★ylosing spondylitis, £‍and reflects Lilly's cuδγλφrrent belief. However, as $®Ωwith any pharmaceutic¥¶al product, there are substantial risks and unc§‌"ertainties in the process of de♠×velopment and commercialization. Among other↔Ω♠  things, there can be no g​↑uarantee that Taltz will receive additional regu©↓latory approvals or be commercially successful. F§€or further discussion of these and oth¥ $er risks and uncertainties, see Lilly'sα÷ most recent Form 10-K and Form 10-Q filings wi‌✘σεth the United States Securiti<¶£↓es and Exchange Commiss∞λ↔₩ion. Except as requiλ§&★red by law, Lilly und≠©→±ertakes no duty to u β‌÷pdate forward-looking statements to reflect even™£λδts after the date of this release.PP-IX-US-2795 λ↔08/2019 © Lilly USA, LLC 2019. Allπ₽↓ rights reserved. Taltz® is★↕ a registered trademark owned or licensed b₩φ™‌y Eli Lilly and Company, i∏§ts subsidiaries, or affiliates.from ₩←'pharma focus aisathe 2019 Asia-pacific ‍↓&<Pharmaceutical IP Leader ™₹ ☆Summit will be held in&ελnbsp;Beijing on November 14-15, <≥↓and will attract more than 500 indust&'∏÷ry experts from domestic and fo ​®♣reign pharmaceutical companies, biotechnoγ♥₩logy companies, governments, associations, law∏☆​ firms, intellectual property age£☆'σnts and other companies to att'£'₽end.Official registration a​∑±∑nd consultation channels:Contact：AnnPhone: 0★®©♣21-65650305Email：Marketing@zenseegro>π¥up.comhttp://en.zenseegroup.com/p♠γ$/510934/