Lilly Receives U.S. FDA★≤" Approval for Taltz® (ixekiz★¶umab) for the Treatment of Active A ©nkylosing Spondylitis (Radiographic ♣↔™ Axial Spondyloarthritis)
Eli Lilly and Company announced today that th↕<±e U.S. Food and Drug Administr¥∞÷♣ation (FDA) has apprγ∑oved Taltz® (ixekizumab) injection 8↓"0 mg/mL for the treatment o↕Ω<αf adults with active ankylosiγ✔ng spondylitis (AS), also known as radiogβ>₩↔raphic axial spondyloarthritis (r-axSpA).This →☆is the third indication for Tal←' tz, which was first approπ ±÷ved by the FDA in March 2016 for t•♣he treatment of mode♦∑™πrate to severe plaque psδ oriasis in adult patients wh€★o are candidates for systemic therapy o>™✔€r phototherapy and theε≤¥γn approved by the FDA in December 2σ ∑017 for the treatment of adults with₩Ω active psoriatic arthritis."Ankylosing spondy≠™ "litis is a challenging disease&★ that can cause severe back pain and if left u$ε≈ntreated, can significantly impa$→ct patient mobility," said Rebecca Morison, vic >e president, U.S. Immunology at Lilly. "We ↑"are excited to now offer Taltz as↕γ♦ a treatment option for people in need of reliefε from the symptoms of AS. This appro↑γ≠val further underscores Lilly's commitment ÷ to helping people living with rheumaticπ≥ diseases."Taltz may be adm÷σ↔inistered alone or in combination with '∏&✘a conventional disease-modifying antirheuma•✔tic drug (e.g. sulfasalazine), cort& icosteroids, non-steroidal anti-inflammatory d↕£rugs (NSAIDs) and/or anal×±€gesics. Taltz should not be used in patient₹™βs with a previous seriou≥≠ s hypersensitivity, su✔★>ch as anaphylaxis, to ixeki↕××∏zumab or to any of the excipients. Taltz m↓'♠≠ay increase the risk of infection. Other warnings and precauti£ons for Taltz include prδ'¶e-treatment evaluation for tuberculosis,>>★ hypersensitivity, inflammatory bowel §↑®€disease, and immunizations. See Important Saf♦γ<≤ety Information below.AS is a type of spoε↕ndyloarthritis that affects the pelvic joints an ♣✔d spine, and can be characteriz←✘→ed by chronic inflammaδ tory back pain, stiffness and impaired fuδ÷♠¥nction and mobility.1 AS is estimated to impact♠₽ approximately 1.6 million↑ people in the U.S.2"Having new treatmeα≠δnt options for the ankylosing spondylitis commun©> ≈ity is truly encouraging," said Cas≠ βsie Shafer, chief executiv→♦e officer of the Spondylitis Associat€<₽ion of America. "The ongoing focus t¶✔€o help people impacted by t₩$π&he disease will hopefully leλα ×ad us to an eventual cure."The efficacy and ≤αsafety of Taltz in AS wa&™♦s demonstrated in tw®÷§γo randomized, double-blind, placebo∞₩"-controlled Phase 3 studies that inclu≠δded 657 adult patients with active AS: COAST-★ ₽V in patients who are biologic disease-modif£₹ying antirheumatic drug (bDMARD)-na✘∞₹™ïve and COAST-W in patie€ σnts who previously had an inadequate responseε$ or were intolerant to tumo•φr necrosis factor (TNF) inhibitors.In εΩ ←both studies, the primary efficacy endpoint∑•↑γ was the proportion of✘↑< patients at 16 weeks ac★✔hieving Assessment of Spondyloarthritis Intern♠∑ational Society 40 (AS♠±AS40) response compared♥•≥ to placebo. ASAS40 measures disease signs and ™αsymptoms such as pain, i£σεnflammation and funct∞δion. The COAST clinic§©al trial program incl♥γudes the first and only registrat¶£φion trials in AS to achieve ASAS40←↔∞ response at 16 weeks as a primary eα≈$&ndpoint. Results from both studies demonst>©•rated that patients treated with Taltz ach$ ieved statistically significant and σ≠clinically meaningful improvements in signs and∑•γ symptoms, as defined by ASAS40 ¶≥€response, compared to placebo. At♦ ¥ 16 weeks, patients achieved ASAS40 at t♥'he following response rates:COAST-V: 48 pe↑'rcent of patients treated with Taltz every fo ur weeks versus 18 percent of patients γ↓treated with placebo (p<0.0001)COAST-W: 25 per♥ ✘cent of patients trea&απted with Taltz every four weeks versus 13<® percent of patients treated with placebo (p&↑φ₩↑lt;0.05)Additionally, pa∞≠ tients treated with Talt& z demonstrated statisti€λ¥cally significant improvemαש>ents in key secondary endpoints in both s φ≥φtudies, including the propo₽∏πrtion of patients at 16 weeks achieving A≠¥SAS20 at the following response rates:COAST-V: 6♣β★4 percent of patients treated with Ta←§₹×ltz every four weeks versus 40 percent o<¶ γf patients treated with placeb₽₽β♠o (p=0.0015)COAST-W: 48 percent₩βσ≥ of patients treated with Taltz every four weαΩ✘eks versus 30 percent of patients treated with≠₹ placebo (p<0.01)Over♦→all, the safety profile observed in pati₩∑ents with AS treated with Taltz is consistent₹ with the safety profi¶'☆le in patients with psorias∑π≈is."Results from the Phase 3 clinical trial p"εγrogram in ankylosing spondylitis show that T¶♠α£altz helped reduce pain an±λ<λd inflammation and i≥×∞mprove function in patie ∞ε♥nts who had never been treated with a ☆∑↑bDMARD as well as tho₩₩↓se who previously failed TNF inhibitors,"©€↕α said Philip Mease, M.D.↓™ , Swedish Medical Center/Providence St. Jo÷♥₩seph Health and University of W≥≤ "ashington. "This appλπroval is an important milestone for p₹ →atients and physicians who are →↔£looking for a much-needed "© alternative to address ₹★£®symptoms of AS."Lilly will work with in↔↓Ω✔surers, health systems and providφ∞"★ers to ensure patients are able to access this σ✘treatment. Patients, physicians, pharm φ$acists or other healt×÷hcare professionals with questio♠•¶£ns about Taltz should contact Th☆↔α∑e Lilly Answers Center at 1-800-LillyRx (1★♠φ-800-545-5979) or visit www.lilly.com.Indica∞§tionsTaltz is approved for the treaφ♣εtment of adults with active ankylosi¥ng spondylitis. Taltz is also approved for t ₹÷he treatment of adults with activ↓₩α≈e psoriatic arthritis and §∑€adults with moderate to severe plaque psorias★÷ is who are candidates for systemic therapy or pho$✘→©totherapy.IMPORTANT SAFETYσ × INFORMATIONCONTRAINDICATIONSTaltz i ¥₹>s contraindicated in patients wit•₽h a previous serious hypersensitiv♠✔ity reaction, such as anap→♠hylaxis, to ixekizumab or to any of the ¥✘∏≥excipients.WARNINGS AND PRECA∏φUTIONSInfectionsTaltz may increase the &✘ risk of infection. In clinical trials of p£atients with plaque psoriasis, the Taltz group haπφαd a higher rate of infection≈σ₹&s than the placebo group (27% v←×™₹s 23%). A similar incr↓>$ease in risk of infection was seen∑δ₩ in placebo-controlled trials of pati•ε☆★ents with psoriatic arthritis and ankyl✘<↓osing spondylitis. Serious infections>≈↕∑ have occurred. Instruct patientsσ∑δ✔ to seek medical advice if signs or symp>α♠toms of clinically import ™ant chronic or acute infection occur★& . If a serious infection de★♠♦velops, discontinue Taltz u±©≤ntil the infection resolves.Pre-Treatm→★¶ent Evaluation for TuberculosisEvaluate paσφ♠≈tients for tuberculosis (TB) i β∞nfection prior to initiating treatment with>$™ Taltz. Do not administer to patie$♦★nts with active TB infection. Initiate treatme≤≤ nt of latent TB prior to admi'₩∞nistering Taltz. Closely monitor£→ patients receiving Taltz for signs an"↕d symptoms of active TB during and after treatα ↕ment.HypersensitivitySerious hypersensit★" ivity reactions, including angioed™∏ema and urticaria (each ≤" €±0.1%), occurred in the Taltz£™ group in clinical trials. An™β•₽aphylaxis, including cases leading to ho₽πspitalization, has been reported ↑✘in post-marketing use with Taltz. If a serio€$←us hypersensitivity reaction φ★≈occurs, discontinue Taltz immediatelγ↑₽y and initiate appropriate therapy.Inflammato∏★ry Bowel DiseaseDuring Taltz treatment, monitor φβ↑patients for onset or exacerbations↓$§ of inflammatory bowel disease. Crohn's di₽¥≈sease and ulcerative colitis, inclε"≤♦uding exacerbations, occurredπ↔ at a greater frequency in the Taltz 80 mg Q2€λW group (Crohn's disease 0.1%, →γulcerative colitis 0.2%) than in the placebo gro®→up (0%) during clinical trials in pati•↕™↕ents with plaque psorias§& ¶is and in the Taltz Q4W group in a§"nkylosing spondylitis trials (Crohn's disease 1>".0% [2 patients], ulcerative colitis 0.5% ['Ω1 patient]) than in the placebo group (Crohn's ≥>↔disease 0.5% [1 patient], ulcera¥€tive colitis 0%). In the¥$ ankylosing spondylitis t↓φαrials, serious events occurre→★d in 1 patient in the Taltz group a∞φnd 1 patient in the placebo '∞Ω←group.ImmunizationsPrio §→λr to initiating therapy with Taltz♦π¶, consider completion of all age-appropriate immβ←÷↕unizations according to current'✔ immunization guidelines. Avoid use of live vacci<>nes in patients treated with Taltφ™z.ADVERSE REACTIONSMost comm↔ ≠on adverse reactions (≥1%) associated with Taltz >> treatment are injection site reactions, uπγpper respiratory tract infections, naσ usea, and tinea infections. Overall, the safα€ety profiles observed in patients with psor§∏¶©iatic arthritis and anky↑÷losing spondylitis were consistent with t₩↔ he safety profile in patients with÷ plaque psoriasis, with the exφ¶ception of influenza and conjunctivitis in ps÷oriatic arthritis.Please see full Prescr$♠∑ibing Information and Medication♠®✘ Guide for Taltz. See Instructions for Use in✔γ∏cluded with the device.IX H¥★CP ISI 23AUG2019About Taltz®Taltz® (ixekizumab) i®£'s a monoclonal antibody that s♠∞electively binds with interl✔↑eukin 17A (IL-17A) cytokine and inhibits its i<§εnteraction with the IL-17 receptor. IL-17A is a n¶₹ aturally occurring cytokine that is in÷× ★volved in normal inflammatory and♣∑ immune responses. Taltz inh≈♣ibits the release of pro-inflammatory cytokine∞s and chemokines.About Lilly inβ♥β♦ ImmunologyLilly is bri®→nging our heritage of championiα♥✔γng groundbreaking, novel sβ↕↓Ωcience to immunology"←$≥ and is driven to change δ↕←✘what's possible for people living wit↓§÷h autoimmune diseases. There πσΩ∑are still significant unmet needs, as well a¥↑ s personal and societal costs, for peop∑✔le living with a variety of autoimmune diα"↓₹seases and our goal is to minimize the burde★αn of disease. Lilly is investing in ™π₽£leading-edge clinical ₽₹approaches across our immunology portfolio in hop>¶¥ es of transforming t★♥×he autoimmune disease t¶→π←reatment experience. We've built a≤↔ deep pipeline and are focused on advancing cu$✘tting edge science to find new treatment♠§←s that offer meaningful improvements to suppor✔✔t the people and the communities we serve.Aboutα₽£ Eli Lilly and CompanyLilly is a global healt☆×h care leader that uni₩↓λtes caring with discovery to create ∑¥✔medicines that make life bett☆Ω×∞er for people around the wo↑φrld. We were founded more than a centur♣Ωy ago by a man committed to creating hig✘'h-quality medicines that meet real needs,≥♣↔ and today we remain true to t™§hat mission in all our work. Across the g<∞∞lobe, Lilly employees work to discover and brinαΩ®g life-changing medicines to those who need ©λ≥them, improve the understanding and m£©$anagement of disease, and give back t→ λo communities through philanthropy and volunteeri↑®sm. To learn more about Lill✘☆y, please visit us at lil&↓ly.com and lilly.com/newsroom.∞↑ ← P-LLYThis press release contains forwa✔✔rd-looking statements (as that term is dδδ>₩efined in the Private ☆©εSecurities Litigation Reform Act of 1995) about'§∏♥ Taltz (ixekizumab) as a treatment for ankylosi☆¶≥ng spondylitis, and reflects Lilly's current bel♦₩ief. However, as with any pharmaceutical p&¥γroduct, there are subst♣£≤antial risks and uncertainties ≥'©'in the process of development and co×♣≠mmercialization. Among other thing↑♠≠s, there can be no guarantee that Taltz will rec§π≤δeive additional regulatory approvals or§★ be commercially successful. For further dλ¥iscussion of these and '←'>other risks and uncertainties, see Lilly's mo×₹st recent Form 10-K and Form 10-Q filing±×s with the United States Securities an₽•d Exchange Commission. Except as require∑♦→•d by law, Lilly undertakes no duty to update fπ¶π≈orward-looking statements to reflect ev£β∑ents after the date ש→αof this release.PP-IX-US-2795 08 £α/2019 © Lilly USA, LLC 2019. All rights ¥ε→reserved. Taltz® is a registered tradem ©ark owned or licensed by Eli Lilly and Company, i§☆ts subsidiaries, or affiliates.from p★σharma focus aisathe 2019 Asia-pacific Phar>£∞πmaceutical IP Leader S©§ummit will be held ♣≥ in Beijing on÷β> November 14-15, and will attract more than≤≠ 500 industry experts•¥₽ from domestic and foreign pharmaceutical com₽×panies, biotechnology companies, governments, ass¶λ♥ociations, law firms, intellectual "☆property agents and other companies →↕§↓to attend.Official regi✔ΩΩstration and consultation $∏≈channels:Contact:AnnPhone: 021-65650305Email:Ma↕≥™rketing@zenseegroup.comhttp://en.zen ≈seegroup.com/p/510934/