The U.S. Food and Drug Administratioπ&n today approved Ofev (nintedanib) cap✔Ω↕•sules to slow the rate of de₹ ×↑cline in pulmonary function i<α™"n adults with interstiti® al lung disease associated with®&₽ systemic sclerosis or scle↔←roderma, called SSc-ILD. It is the‍' first FDA-approved treatm₩←™∑ent for this rare lung condition."Patients suf§☆®™fering from scleroderma need effective therapies≤≈≠☆, and the FDA supports the efforts of×₹£δ drug companies that are designing and c"↓β→onducting the clinical trials necessary to bring<επ treatment options to scleroderma patient×<↓ s," said Nikolay Nikolov, M.D., as←♦sociate director for Rheumatology of the Divis₩∑¶ion of Pulmonary, Aller↑₹↑gy, and Rheumatology Products in the FDA's Ce↑☆£nter for Drug Evaluation and Resear♦≤ch. "Nintedanib is now a treatment option to slo®•<πw the rate of decline in pulmonary function★☆ in patients who have interstitial lung§δδλ disease from scleroderma."Sc©∞≈leroderma is a rare disease tha↑§♥'t causes tissue throug↓§>hout the body, including the lungs↑€λ‍ and other organs, to thicken a₩©↔αnd scar. Interstitial lung disease or ILDα✘✔ is a condition affectinΩ™g the interstitium, which is par∏✔t of the lung's structure, and is>β one of the most common disease manifest ε→ations of sclerderma. SSc-ILD is a®±& progressive lung di€¶sease in which lung function dec©☆≠‍lines over time, and it c£←an be debilitating and life-"↕"÷threatening. ILD is the leadi€<ng cause of death among people with scler₽☆®oderma, typically resultiε×ng from a loss of pulmon∏λary function that occurs wheΩε∞n the lungs cannot supply enough oxy≥≠¶↓gen to the heart. Approximately 10₽δ>♥0,000 individuals in the United States h♠‌±Ωave scleroderma, and approxiπ‌mately half of sclerδ ∞oderma patients have SSc-ILD.The effectiλ'veness of Ofev to treat Sλα∑≈Sc-ILD was studied in a raε±₩ndomized, double-blind, placebo-controlled γ≠×trial of 576 patients ages 2≈φδ0-79 with the disease. Patients receiγ​δved treatment for 52 we☆©π∑eks, with some patients treated up to Ω‍★>100 weeks. The primary test fo ×≥βr efficacy measured the forced v≈↕‍ital capacity, or FVC, which is a measure o>↑f lung function, defined as the amount of air th↑©at can be forcibly exσ₩≈haled from the lungs after taking ↑σ¶φthe deepest breath possible. Those who took Of∞ ev had less lung function de→$>✔cline compared to those on pl​₽קacebo.The overall safety profile observed in♠↔£  the Ofev treatment group←∞₩α was consistent with the known safety profile of ©∑¥↓the therapy. The most frequent serious adver <se event reported in patients treated with€♦∏  Ofev was pneumonia (2.8% Ofev vs. 0.3% p∞♥"¥lacebo). Adverse reactions leading to permane✘≈÷↔nt dose reductions w↑γ‌☆ere reported in 34% of Ofev-trλδeated patients compared to 4% of→£★ placebo-treated patients. Diarrhea was the&¥ most frequent adverse reaction♥§☆ that led to permanent dose reduction in patients↓→& treated with Ofev.The preφ §'scribing information for Ofev inclu♦↑₩des warnings for patients with moderate±♣‍ or severe hepatic (liver) impairment, those witα±>h elevated liver enzymes and drug-induced liv§©<>er injury and patients with gastroinδ✔‍βtestinal disorders. Ofev "∑₽may also cause embryo-fetal toxic₹₩ity that can result ♠α in fetal harm, arterial thromboembol↑>ic events (blood clots ♣¥π), bleeding and gastrointestinal perfora®<tion. P-gp and CYP3A4 inhibitors may increase nin ε™♠tedanib exposure, and pati✘α∞✘ents taking these inhibitors sho↓φuld be closely monitored for tolera₹πbility of Ofev. Common side effects'βλ noted with Ofev include diar  ​rhea, nausea, abdominal pain, vomiting, liver ¥​enzyme elevation, decreased appeε←πεtite, headache, weig‍♠≠•ht loss and hypertension (high blood$≤ pressure).Ofev was originalα$≤ly approved in 2014 for adult patient≥♥λs with idiopathic pulmonary fibr→↑osis (IPF), which is another interstitial lu∞§ng condition.Ofev received Priority Rev"★₩→iew designation, under which the FDA's goal ®§ →is to take action on an application within ★β♣six months where the agency det>γσermines that the drug,→< if approved, would significan"↑®​tly improve the safety or effectivenes÷£×s of treating, diagnosing or pr'≈eventing a serious condition. Ofev also r≠$¥eceived Orphan Drug designation, which provides i©★ncentives to assist and encourage the de←≤₽velopment of drugs for rare diseases.The FDA σ‌₹​granted the approval of Ofev to treat SSc-IL÷<♣♦D to Boehringer Ingelheim Pharma≥‍∑$ceuticals Inc.The FDA, an agency wit<€→hin the U.S. Department of Health and Human Serv<€ices, protects the public health by assuring t♣↔he safety, effectiveness, and security o♥→f human and veterinary drugs, vacci©απnes and other biological products for hu&×¥£man use, and medical devices. The age∞↑ncy also is responsible"♦ for the safety and security of ✘< our nation's food supply, cos☆←≈£metics, dietary supplements,±$<↓ products that give off electronicγσ' radiation, and for regulatin∏★g tobacco products.Media Inquiri€≤es: Nathan Arnold, 301-796-6248, nathan.→®←arnold@fda.hhs.govConsuβ'mer Inquiries: 888-INFO-FDA201λ¥≤'9 Asia-pacific pharma •ε≥IP Leader Summit: http://en.zenseegroup.com/p/510≤$¶934/ will be held in&nb>$sp;Beijing  o↕∏'↓n November 14-15, and will attract moreλσ  than 500 industry experts from domestic ₽​Ω>and foreign pharmaceutical companies, biot©≤× echnology companies, governments, ∞ <‌associations, law firms, intellectual property a★ gents and other companies to att₽• ​end.Official registration and consultation ch₽↕annels:Contact：AnnPhone: 021-6π> 5650305Email：Marketing@zens®∞₩eegroup.comhttp://en.zenseegroup.com/p/510934/