The U.S. Food and Drug Administration →♠×≠today approved Ofev (nintedanib) caps™>ules to slow the rate of decline ↔♦©♦in pulmonary function in adults with ♥∏interstitial lung disease ass↔×£πociated with systemic sclero♦λsis or scleroderma, called SSc-ILD. It isλ₹± the first FDA-approved treatment for t≥©his rare lung condition."Patients suffering from≠α scleroderma need effect♦§×ive therapies, and the FDA supports the e>←£★fforts of drug companies that are designing and c©•∑↓onducting the clinical tri ¥als necessary to bring treatm ‌ent options to scleroderma patients,✘< " said Nikolay Nikolφ ≤ov, M.D., associate director for Rheumatology of↓σ← the Division of Pul™>✔₹monary, Allergy, and Rheumatology Product♠♣×s in the FDA's Center for Drug Evaluation  £φ÷and Research. "Nintedanib is now a treatmen★‍'&t option to slow the rate of de£§≤cline in pulmonary function in patien ♦ts who have interstitial lung d ∏•♥isease from scleroderma."Scleσ✔♠'roderma is a rare disease that causes tissε∏ue throughout the body, including the lungs ≠←π☆and other organs, to thicken δγ↕≈and scar. Interstitial lung♦β disease or ILD is a condition affecting t₹®>he interstitium, which is part of the lung'≈×♠s structure, and is on™♠↑e of the most common d∞α✔isease manifestations of sclerderma. SSc-I•×£LD is a progressive lung di×‍σ↔sease in which lung function declines  ‌‌✔over time, and it can be debilitating an<>♥d life-threatening. ILD Ω✘φσis the leading cause of★↕≤ death among people wit¶‌♠γh scleroderma, typically resulting from a l  ↑‍oss of pulmonary function that occ★↑¥urs when the lungs cannot &↔φεsupply enough oxygen to the heart←÷. Approximately 100,000 individu€↕als in the United States have scleroderma, and ©ε §approximately half of scleroderma patients have S☆δ'φSc-ILD.The effectiveness of Ofev to treat ←₹£SSc-ILD was studied in a randomized, double-bliε₹nd, placebo-controlled trial of 576 patients agesΩ‍ α 20-79 with the disease. Patients received treatm‍₹♣ent for 52 weeks, with some patients treated uβ‍₹p to 100 weeks. The primary test for effic≠¥‍♦acy measured the forced vit♦<♠al capacity, or FVC, which is a measure o©≠f lung function, defined as the amount of ai‌☆$r that can be forcibly exha>×&led from the lungs after taking the de₹®♥epest breath possible. Tho$&← se who took Ofev had less lung function d©♦±ecline compared to those on•δ placebo.The overall safety  ✘profile observed in the  πOfev treatment group was consistent with the know‍↑n safety profile of t↔¥he therapy. The most frequent serious adverse <π§event reported in patients trea≠ ted with Ofev was pneum ☆onia (2.8% Ofev vs. 0.3% placebo). Adverse rea Ω↕γctions leading to permanent dose r≠♣↔eductions were reported in 34% of Ofev-treated pa€✔€→tients compared to 4% of placebo-treate±↓d patients. Diarrhea was the most fr​£←✔equent adverse reaction that led to permanent d↓"¶>ose reduction in patients treated with Ofev.Th§'e prescribing information for Ofev includes∏ ✘ warnings for patients with mod¥φ§erate or severe hepat¶↑×ic (liver) impairment‍$ ♠, those with elevated liver enzyme✔∑s and drug-induced liver injury and patien★≤♠™ts with gastrointestinal d φ‌≤isorders. Ofev may also cau• ★≥se embryo-fetal toxicity that can∑≥<← result in fetal harm, ←λarterial thromboembolic events (blood clots), b‌​leeding and gastrointestinal perforation.™∞↑ P-gp and CYP3A4 inhibitors may increase nint<φ→☆edanib exposure, and patients taking these ≤≥inhibitors should be closely monito&<red for tolerability of Ofev. Common side effect"& s noted with Ofev include diarrhea, nausea, ₩↔abdominal pain, vomiting, liver enzσ®∞yme elevation, decre→↑→∏ased appetite, headach±♥♣e, weight loss and hypertension (high ÷←blood pressure).Ofev was originally appro↔★ved in 2014 for adult p↑↓→atients with idiopathic pulmonary fibrosis (IPF€± ≈), which is another interstitialσ ®α lung condition.Ofev received Priority Review d≤₽♣$esignation, under which th"←e FDA's goal is to take action on an λ♠×εapplication within six months where the agency  ₩§&determines that the drug, if approved, wo​↑₽☆uld significantly improve the safety π♥or effectiveness of treating, σ §≈diagnosing or preventing₽∏ a serious condition. Ofev also rece§≈ived Orphan Drug designation, which pro"↑vides incentives to assist and encourage the d>β∞★evelopment of drugs for ¶€★rare diseases.The FDA grante★π→d the approval of Ofev to treat SS™ →₽c-ILD to Boehringer Ingelheim Pharmaceuticals♦∑ Inc.The FDA, an agency within thγδ♦e U.S. Department of He♠​♥☆alth and Human Services, protects the ☆>≤public health by assuring the ™™'↓safety, effectiveness, and securit&γ¶y of human and veterinary drugs, vaccines an≠♥d other biological products for human use, an♦×β★d medical devices. The agency alε₽∞so is responsible for the safety and seα✔∑ curity of our nation's foo'<d supply, cosmetics, ≈λ♣ dietary supplements, products that give of♥'f electronic radiation, and for regulating tobac♦"✘¥co products.Media Inquiries: →♠;Nathan Arnold, 301-796-6248, nathβ≤<an.arnold@fda.hhs.govConsumer Inquiries§•♣←: 888-INFO-FDA2019 Asia-pacific pharma IP Lead♣π✔er Summit: http://en.zenseegroup.cε↕↓om/p/510934/ will €→φσbe held in Beijing  on&n γ✘≈bsp;November 14-15, andα™♥ will attract more than 500 industry expert₹→s from domestic and fo≠>reign pharmaceutical companies,​& biotechnology companies, governments, associ∞☆‌£ations, law firms, intellectual prop★•σerty agents and other com♣ panies to attend.Official registration a‍₩©nd consultation channels:Contact：AnnPhone:✘≠‌ 021-65650305Email：MaεΩrketing@zenseegroup.comhttp://en.zensλ₹♣eegroup.com/p/510934/