The U.S. Food and Drug Administration toδ<day approved Ofev (nin₽ Ω>tedanib) capsules to slow the rate of♣' decline in pulmonary function in adults ®δwith interstitial lungε÷ disease associated with systemic sclerosis or ¶≥∏¥scleroderma, called SSc-ILD. It is the first↑₩ FDA-approved treatment fo¥©$r this rare lung condition."Patients✘♦ suffering from scleroderma need effectiσ£≤ve therapies, and the FDA supports ♦πthe efforts of drug companies that a£₩re designing and conducting the clinical tri​♦als necessary to bring treatment options to sc™'×leroderma patients," said Nikolay Nik•Ω₩olov, M.D., associate director for Rheumat♥∞≈ology of the Division of P'☆ulmonary, Allergy, and↓&∞ Rheumatology Products in the γ₩FDA's Center for Druγ™φ€g Evaluation and Research. "Nintedanib iδ☆ ♥s now a treatment option to slow↓® the rate of decline in pulmφ♦βonary function in patienγ‌•ts who have interstitial lung disease∞∑ from scleroderma."Scleroderma is a rare φ&¶disease that causes t→λ↑issue throughout the body, including the lung×™φ♠s and other organs, to thicken and scar.♦✘ Interstitial lung disease ¶γ↕Ωor ILD is a condition affecting tφ↔he interstitium, which is part of the lung§• 's structure, and is one of the most common₽< disease manifestations of sclerderma.↔∏  SSc-ILD is a progressiα ★¥ve lung disease in which lung func ↓$tion declines over time, and it can be deb©€ilitating and life-threatenin↔ε®g. ILD is the leading cause of death among peo↔​♠ple with scleroderma,​•₩× typically resulting from a loss of p♥←εulmonary function that o©≠ccurs when the lungs cann ≈✔ot supply enough oxygen to the he>©βart. Approximately 1★≠‌γ00,000 individuals in the U‍Ω∞nited States have scleroderφ ma, and approximately half of scleroderma$≠∞ patients have SSc-ILD.T∑‍♠he effectiveness of Ofev to treat SS•₹c-ILD was studied in a randomized, δ¶÷double-blind, placebo-controlle↕★↔d trial of 576 patients ages 20-79 with the diβ♠ sease. Patients received treatment for 52 weeks,¶₩‍¶ with some patients t∞≥reated up to 100 weeks. The primary t →∞est for efficacy measured the forced vital">λ capacity, or FVC, which is a 'γ×∑measure of lung func↑→<tion, defined as the amount of a€¥&ir that can be forcibly exhaled✘ ×$ from the lungs after taki✘δ₽ng the deepest breath ★$÷possible. Those who took Ofev had less l✘¶ung function decline compared to those on pla♠β§cebo.The overall safety profile obser♠≤¶ved in the Ofev treatment‍∞₹λ group was consistent wit€<∏×h the known safety profile of the therapy. Th§♠®γe most frequent serious adveδ‍±rse event reported in pat♥φients treated with Ofev wΩγas pneumonia (2.8% Ofev vs.β∑ 0.3% placebo). Adverse reactions lπ≥≥‌eading to permanent dose reductions were repoΩ∏₽∑rted in 34% of Ofev-treated ≠σ patients compared to 4% of placebo-tre₩★÷©ated patients. Diarrhea was the ♣♦δmost frequent adverse reaction tha$€t led to permanent dose↑§ reduction in patients treateε​d with Ofev.The prescribing information for Ofe∏←βv includes warnings for patients←✘£ with moderate or severe hepatic (liver) impair§€↓ment, those with elev₽™∏‌ated liver enzymes and∑​ drug-induced liver in§♠>jury and patients with ga✔α≈strointestinal disorders. Ofev ma≈↕♦£y also cause embryo-fetal toxic™£α ity that can result in fetal harm, arterial ∏×✘thromboembolic events ♣σ(blood clots), bleeding€↑ and gastrointestinal perforation. P-gp and CYP3A↔φ 4 inhibitors may increase nin±φ •tedanib exposure, and pati§ ★ ents taking these inhibito∑✘rs should be closely monitored for tole¥←‍≥rability of Ofev. Common side effects no↕€Ω¶ted with Ofev include☆β diarrhea, nausea, a'♣δ♥bdominal pain, vomiting, li ¶♠ver enzyme elevation, decreased appetite, headach∏★e, weight loss and hypertension (high blood δ¥ε$pressure).Ofev was originaε>↔¶lly approved in 2014 for adult patients with >↕idiopathic pulmonary fi  brosis (IPF), which is anoth←™er interstitial lung condition.Ofev rec♠£®eived Priority Review designation, unβ©₽>der which the FDA's goal is to ↔§take action on an application wi&‌☆'thin six months where the agency determines © ≠that the drug, if approved, would significanΩ₹→αtly improve the safety o↕££r effectiveness of treating, diagnosing or pr•€♣"eventing a serious condition. Ofe↓₩v also received Orphan Drug designλ₩ation, which provides incent↕>φ&ives to assist and encourage the development ↑λof drugs for rare diαπ¥ seases.The FDA granted the approval of Oλ<♣ fev to treat SSc-ILD to™δ♣ Boehringer Ingelheim Pharmaceuticals Inc.Th©¥∞e FDA, an agency withi¥✔÷∑n the U.S. Department of Health and Human Ser≤↔¶vices, protects the public heal©£th by assuring the safety, effectivenes₩α≠¥s, and security of human and veterinary dr'↕®ugs, vaccines and other biological products for"> human use, and medical devices. The ag×≠λency also is responsible for the safety a÷ε®nd security of our natio≤‍>n's food supply, cosmetics, dietary supple<₩ments, products that give off§₹Ω  electronic radiation, and fo‍ £r regulating tobacco products.Media Inq‌÷>→uiries: Nathan Arnold, 301-796-6248, nathan$↓•≠.arnold@fda.hhs.govConsumer Inquiries: €☆ 888-INFO-FDA2019 Asia-pa♣σcific pharma IP Leader Summit: http://en.zenseeγ¶≈¶group.com/p/510934/ will be held÷¶ in Beijing &nb₩≠sp;on November 14-15, and w> ill attract more than 500 indust÷αδ™ry experts from domestic and foλ≤​reign pharmaceutical c  ∞ompanies, biotechnology companies, govern∞‌ments, associations, law firms, inte£≤φllectual property agents and other  ®☆ companies to attend.Official registration ☆∏and consultation channel ♠→s:Contact：AnnPhone: 021-65650305Email：Marke₹'<₹ting@zenseegroup.comhttp://en.zenseegroup.<Ωδ¥com/p/510934/