Eli Lilly and Company announced₩"₹ today that the U.S. Food and Drug Adα£ministration (FDA) has approved Taltz® (ixekiz'¶☆♣umab) injection 80 mg•Ω♣/mL for the treatment of adults with active ankyl✔→osing spondylitis (AS), also known as r✔♣₹adiographic axial spondyloarthritis (r-axSpA).

This is the third indication fδ≤or Taltz, which was first approved★₹ by the FDA in March 2016 fo→∞♦r the treatment of moderate to severe plaque ps<♥γoriasis in adult patients wh☆♦↑Ωo are candidates for systemic therapy γλor phototherapy and then approveβ¥$₹d by the FDA in December 2017 for t€↓±δhe treatment of adults w✘₹ith active psoriatic arthritis™♣​.

"Ankylosing spondylitis is a challengin↓βg disease that can ca→✘★use severe back pain and i™♥∞f left untreated, can significantly impact → patient mobility," said Rebeccaα€$ Morison, vice president, U.S. Immunλ® ology at Lilly. "We are excited to §λnow offer Taltz as a treatment opti'←↕∏on for people in need of reli®±ef from the symptoms of AS. This approval ‌<further underscores Lilly↑'•'s commitment to helping people liv→★€ing with rheumatic diseases."

Taltz may be administer​​ed alone or in combination withα'↕ a conventional disease-modifying ant÷¶irheumatic drug (e.g. sulfasalazine),‍​≥ corticosteroids, non-steroi© ≈dal anti-inflammatory drugs (NSAIDs) a→×<↑nd/or analgesics. Taltz sho★δλ∑uld not be used in patients wit✔γh a previous serious §←hypersensitivity, such as anaphy✔≠laxis, to ixekizumab or to any of t ‍'he excipients. Taltz may increase the α✔↕↑risk of infection. Other warnings a♠↕±×nd precautions for Taltz include pre-treα£atment evaluation for tuberculosis, hypersensitiv ₹ity, inflammatory bowel disease, and immuni≥♣zations. See Important Safety Informati→✘on below.

AS is a type of spondyloarthritis that affects t₽♣σhe pelvic joints and spine, 'αand can be characterized by chronic infla₹♥™mmatory back pain, stiffness a¶γγ¶nd impaired function an ♦★d mobility.1 AS is estimated δ  to impact approximately 1.6 million p→→eople in the U.S.2

"Having new treatment opt≈✔ions for the ankylosing spondylitis community is ‌‌∞λtruly encouraging," '• ≠said Cassie Shafer, chief execβ<±​utive officer of the Spondylitis≥Ω Association of America. "The ongoing focus שto help people impacted by the d£™•↕isease will hopefully lead us to an eveδ÷π ntual cure."

The efficacy and safety of÷€<≈ Taltz in AS was demonstrated in two rando™★mized, double-blind, placebo-controll☆←×ed Phase 3 studies that inclu✘♥ded 657 adult patients with active AS: COAST-₹​×V in patients who are biologic disease-modifying∑σ≠™ antirheumatic drug (bDMARD ∞)-naïve and COAST-W in pat'≤ients who previously had an inadequate respαφ‍φonse or were intolerant to tumor necrosis f​' actor (TNF) inhibitors.

In both studies, the primary efficacy φ¥ endpoint was the proportion of patients at 1&₹<6 weeks achieving Assessment of Spondyloarthritλ&↔£is International Society 40 (A₩$​SAS40) response compared to placebo. AS§§AS40 measures disease signs and sympto₽↔ms such as pain, inflammation a≈←♠≥nd function. The COAST clinical trial pr✔$₩ogram includes the first and only r™δegistration trials in AS to achieve ASAS40 resp"‍•₽onse at 16 weeks as a prim↕★‍♥ary endpoint. Results from both s →β tudies demonstrated that pati‌±¥φents treated with Taltz achieved s♦≠>&tatistically significant and clinically mean≈£ingful improvements in sign∑σ s and symptoms, as defined φπby ASAS40 response, compared to placebo. ∑ ↔↔At 16 weeks, patients achieved ASAS40 at ‍β§÷the following response rates:

COAST-V: 48 percent of patients π treated with Taltz every four weΩ↕©'eks versus 18 percent of patients÷π treated with placebo♥'λ× (p<0.0001)
COAST-W: 25 percent of patients treate★δd with Taltz every four weeks¥€≤≠ versus 13 percent of patientsε♦¥< treated with placebo×♦™→ (p<0.05)
Additionally, patients ✔ treated with Taltz demonstrated statis‌↓¥<tically significant improvements in key secon"✘±®dary endpoints in both studies, including the p£∑←roportion of patients aαπt 16 weeks achieving ASAS20 at the follo☆ ¥×wing response rates:

COAST-V: 64 percent σ→™of patients treated with Taltz every four weeks ∞ σ♦versus 40 percent of patients treated with pla ‌™→cebo (p=0.0015)
COAST-W: 48 percent of patients treε>&ated with Taltz every four weeks versus 30 percen≠"♣★t of patients treated with plac&∑¥ebo (p<0.01)
Overall, the safety profile observeσ♥d in patients with AS treated with Taltz is consiπ¥ε®stent with the safety profile←₩γ$ in patients with psoriasis.

"Results from the Phase 3 clinical trial proγ♥∞φgram in ankylosing spondylitis show that✘γ↑ Taltz helped reduce pain and inflammation an♦$∏d improve function in patients wh>λδ≥o had never been treated with a bDMARD aα ✔→s well as those who previously failed TNF∑¶" inhibitors," said Philip Mease, M.D., Swedish ←←Medical Center/Providence St. Joseph Health ™€® and University of Was≈₹hington. "This approval § is an important milestone for patien≥δ‌‍ts and physicians who are looking for a muc$♥h-needed alternative t₽¶÷λo address symptoms of AS."

Lilly will work with insurers, health system♥↓φπs and providers to ensure patients are ±←εable to access this treatγ←≤$ment. Patients, physicians, pharmacists or other ≥¶✘healthcare professionals with≤↓‍' questions about Taltz should c★αα✘ontact The Lilly Answers Cent ≈er at 1-800-LillyRx (1-800-545-5979) or vi✔€✔↔sit www.lilly.com.

Indications
Taltz is approved for the treatme÷±nt of adults with activ♦​e ankylosing spondylitis. Talt₩§™•z is also approved for the treatmen>γ↕t of adults with activ♥₽$e psoriatic arthritis and ad ∑↓φults with moderate tφ± o severe plaque psori♣∏βasis who are candidates for systemic ther∞₽★apy or phototherapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
Taltz is contraindicated in pat‍™ients with a previous serious hypersensitivity re←÷σ¶action, such as anaphyla♦±xis, to ixekizumab or to any of the ex✔δ$cipients.

WARNINGS AND PRECAUTIONS

Infections
Taltz may increase the risk of infection. In clin§♥ical trials of patients with p±♦laque psoriasis, the Taltz group÷→ had a higher rate of inf∞★↔ections than the placebo group (27% vs 23%). A γ ×σsimilar increase in risk of ‍φ>∞infection was seen in pl↔←★‌acebo-controlled trials of&∑∞> patients with psoriatic arthritis and ankylo♠σ£ sing spondylitis. Serious ♥©₽Ωinfections have occurred. I≥ nstruct patients to seek medical advice if si' gns or symptoms of clinically i ±λmportant chronic or ©€acute infection occur. If a serious infection d€‍↕evelops, discontinue Taltz unti✘÷¥>l the infection resolves.

Pre-Treatment Evaluati"£πon for Tuberculosis
Evaluate patients for tuberculosis (TB) ♣™δ≈infection prior to initiating ₩≈≈>treatment with Taltz. Do not a§→"±dminister to patients ∑Ωφwith active TB infection. Initi✘<∏ate treatment of latent TB p '♥↔rior to administering Taltz. Closely £λmonitor patients receiving Taltz for signs and ☆<♦ symptoms of active TB during an&'≠d after treatment.

Hypersensitivity
Serious hypersensitivity reactions, inc λluding angioedema and urticaria (each ≤0.1%)←δΩ÷, occurred in the Taltz group in clinical ≤$±trials. Anaphylaxis, ₹π​​including cases leading to hospital↓∞ization, has been reported in post-marketing u♦♠✘se with Taltz. If a serious hypersensitivity reaπ£ction occurs, discontinue Taltz immeγ✘λ₽diately and initiate appropriate therapy.

Inflammatory Bowel Di£¶sease
During Taltz treatment, monitor p♣₹€αatients for onset or exacerbations of in ™flammatory bowel dis ♠‍ease. Crohn's disease and ulcerative c♥≈↓∏olitis, including exacer↑€λ∏bations, occurred at a greater  ÷✘frequency in the Taltz 80 mg Q2W g₽δ>∑roup (Crohn's disease 0.1%, ulcerati×∏ve colitis 0.2%) than iε§↓n the placebo group (0%) during clinical tria¶ ls in patients with pl≤>$™aque psoriasis and in the Tal∞®tz Q4W group in ankylosing s<↓™®pondylitis trials (Crohn's di≤∑ sease 1.0% [2 patients], ulcerat &ive colitis 0.5% [1 Ω•™patient]) than in the placebo group (Croh$♥n's disease 0.5% [1 patient], u♥Ωlcerative colitis 0%).β≤♦ In the ankylosing spondφ®ylitis trials, serious events occurred in <$€1 patient in the Taltz group and 1 pat&↓→ient in the placebo group.

Immunizations
Prior to initiating therapy ÷✔₽₹with Taltz, consider>​© completion of all age-a±✘φppropriate immunizations according to cur'>¶rent immunization guidelines. Avoid use of live ¶σ vaccines in patients treated wiα♥γth Taltz.

ADVERSE REACTIONS
Most common adverse reactions (≥1%) associatΩ​↓∑ed with Taltz treatment are injection site ₽'reactions, upper respiratory tract✘φ✘ infections, nausea, and tinea infections‍ ∞​. Overall, the safety profiles observed in pat  αients with psoriatic arthritis and ank£α"≤ylosing spondylitis were consistent with↓↑< the safety profile in patients with Ω‌plaque psoriasis, with the exception of influeσ'↔‍nza and conjunctivitis in psoriatic arthritis.

Please see full Prescribing Informa♠↕≥✔tion and Medication Guide for Ta₩↓<♠ltz. See Instructions for Use included with the dεβ&♥evice.

IX HCP ISI 23AUG2019

About Taltz®
Taltz® (ixekizumab) is a mo  ¥ noclonal antibody that selecti∑™vely binds with interleukin 17A (IL-1→÷×7A) cytokine and inhibits its interaction w♦π"ith the IL-17 receptor. IL-17A is a natur₹∞ally occurring cytokine ≈™<σthat is involved in nor✔λ​ mal inflammatory and immune responses. Tal•→"tz inhibits the release of pro-inflammatory≥×≈¥ cytokines and chemokines.

About Lilly in Immunology
Lilly is bringing our heritage of championing gr♦'¥oundbreaking, novel science to im$↓munology and is driveγ ™n to change what's possible for people livε∑ing with autoimmune diseases. There are still < significant unmet needs, as well as personal •&♣₹and societal costs, for people living with a ↑∞variety of autoimmune di'•®βseases and our goal is to minimize  ☆the burden of disease.β✘σ Lilly is investing in leading-edge cli≤↔nical approaches across our immunology portfolio™™★ in hopes of transforming the autoimmune d✘€isease treatment experience. We've ≠∞₽built a deep pipeline and are focused on advanc×>∞ing cutting edge science to find new treatments>≈ that offer meaningful improvements to support th♠÷e people and the commu $nities we serve.

About Eli Lilly and Company
Lilly is a global health care le>>↔•ader that unites caring with discφ σ←overy to create medicines that ma&σ‌ke life better for people aroun≥→→d the world. We were founded more than a centu¶σ♥‍ry ago by a man commit§ ¥ted to creating high-quaαΩlity medicines that meet real needs,✔®♣  and today we remain true to that mission in ₹Ω₩×all our work. Across the gloσβδβbe, Lilly employees work to discover and br>✔φ ing life-changing medici "↑ nes to those who need them, ‌♣δimprove the understanding and managem±↓₩>ent of disease, and give back♥∑σπ to communities through philanthropy a÷←nd volunteerism. To learn more ab★σ↔out Lilly, please visit us at lilly.com and lil♣'♦λly.com/newsroom.  P-L∞♦LY

This press release contains f &orward-looking statements (as₩δ that term is defined in the Private SecuΩ→rities Litigation Reform Act o↑γf 1995) about Taltz (ixekΩ"₩izumab) as a treatment f↔<or ankylosing spondylitis, and ref₽​‍lects Lilly's current belief. However, ∑↔≠as with any pharmaceutical prod÷​uct, there are substantial risk§©∏'s and uncertainties i&¥"n the process of development and commercializaα☆εtion. Among other things,∑♥ there can be no guarantee that Taltz will re♥≈×ceive additional regulatory appr>↔←ovals or be commercially suα₹≠ccessful. For further d>≤iscussion of these and other risks anΩ∏" d uncertainties, see Lilly's mosβ↓t recent Form 10-K and Form 10-Q filings with t ≤he United States Securities and Ex★♣↓change Commission. Except as required b↓&y law, Lilly undertakes no duty to update forwar©₩¶d-looking statements tπ≤o reflect events after t♥&&he date of this release.

PP-IX-US-2795 08/2019 © Lilly USA, LLC 2019. Al> l rights reserved. Taltz® is a registeredδ$> trademark owned or lice♥∑nsed by Eli Lilly and Com₩¥♠pany, its subsidiaries, or affiliates.

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