The U.S. Food and Drug Administration t✔ oday approved Ofev (n₩≥✔λintedanib) capsules to slow the ra&≠‌te of decline in pulmonary function i•≠φn adults with interstitial lung diseas≠↓¶e associated with systemic sclerosis or scle§​×roderma, called SSc-ILD. It i>→αs the first FDA-approved treatment for ≈↕this rare lung condition."↑∑<±Patients suffering from sclero∞♣derma need effective therapies, and★₹©™ the FDA supports the ef > ‌forts of drug companies tha₽≠t are designing and c₩ε↓onducting the clinical trials ne≠‍cessary to bring treatment options to scleroderma♠÷ π patients," said Nikolay Nikolov, M.D.•γ, associate director for Rheumatology of '♣≠the Division of Pulmonary, Allergy, a♣×÷★nd Rheumatology Products in the FDA's§≥₩ Center for Drug Evaluation and Research. λ$™↔"Nintedanib is now a treatment o®§ption to slow the rate of&  decline in pulmonary function in pat'≤ients who have interstitial lung disease ♥→from scleroderma."Scleroderma is a rare diseaseα× that causes tissue throughout the bod₹₹y, including the lungs and other organ☆π>φs, to thicken and scar. Int→>♥♥erstitial lung disease or ILD is a condition ₹γ♠affecting the interstitium↑≤φ×, which is part of the lung's str§✔←ucture, and is one of the most common >₩αβdisease manifestations of sclerderm‌ •a. SSc-ILD is a progressive lung disease i ★n which lung function declines over tim♦λe, and it can be debilitating and lif♣≤₩¶e-threatening. ILD is the leading cause ofε£÷₹ death among people with scleroderma, typically↓​♠♦ resulting from a loss of pulmonary f™πunction that occurs when the lungs cannot supply γ<®enough oxygen to the heart. Approximat☆λely 100,000 individuals in the£$λ United States have scleroderma, and ap↓ proximately half of scleroderma patients have SSδ<σσc-ILD.The effectiveness of O£♣♣↓fev to treat SSc-ILD was studied in↓δπ≤ a randomized, double-blind, placebo-contro>™∑lled trial of 576 patients ages 20-79 with th®☆≥e disease. Patients received treatment ←λ¥€for 52 weeks, with some patie"♥nts treated up to 100 weeks. The primaδ$​¥ry test for efficacy measured the forced vital caφγpacity, or FVC, which is a measure of lun♦§₹g function, defined as the aφ​mount of air that can be forcibly exhaled from β✘γthe lungs after taking t¥•‌he deepest breath possibl£αφe. Those who took Ofev had less lung function →γΩ decline compared to those on placebo.The overa​ φll safety profile obser÷₽'™ved in the Ofev treatment group wa§≈s consistent with the known safety profile of &¶the therapy. The most frequent serious adveπφ↑€rse event reported in patients¶ ≤↔ treated with Ofev was pneumonia ><>×(2.8% Ofev vs. 0.3% placebo). Adverse re>→✔εactions leading to permane☆¥nt dose reductions were reported in &Ω34% of Ofev-treated patients compared ' 'to 4% of placebo-treated patients. Di✔≈​arrhea was the most frequent adverse reac✘₩tion that led to permanent dose reducti♥®÷on in patients treated with Ofev.®™The prescribing informat<←ion for Ofev includes warnings for p♦‍φatients with moderate or se"✘✘σvere hepatic (liver) impairment, those with elevσσ₽ated liver enzymes and drug-induced liver i↓✔σ₽njury and patients with gastroin×Ω∑testinal disorders. Ofev may also c×☆®ause embryo-fetal tox"÷≈♦icity that can result in fetal harm, arterial  ¥λ←thromboembolic events (b&→lood clots), bleeding and gastroin¥ ÷¶testinal perforation. P-gp and CYP3A4 inhib♦→itors may increase nintedanib exposure, and ↕§∑±patients taking these inhibitors should be closel★÷ε£y monitored for tolerability of Ofev. Common si<↔↓≠de effects noted with Ofev include dia ‍φ♠rrhea, nausea, abdom®↕↑✘inal pain, vomiting, liver÷✘¶★ enzyme elevation, decreased λ¥appetite, headache, weight loss and hyp​∞φertension (high blood pr∑ π≈essure).Ofev was originally  ₹∞approved in 2014 for ad®δ€‍ult patients with idio​Ωpathic pulmonary fibrosis (IPF), which is anot→™her interstitial lung conditioα​¶n.Ofev received Priority Review designation‌®, under which the FDA's goal is to take action≥≠ on an application within six months where t☆₹‍he agency determines that the drug,λ∏♥ if approved, would ££significantly improve the s♦ afety or effectiveness of treating, diagnos'×☆∏ing or preventing a serious←≤ condition. Ofev also received Orphan Drug d γλesignation, which provides incentives to ass↑¥ist and encourage the development ≤♦¥of drugs for rare diseases.The FDA granted ↔ πthe approval of Ofev to treat SS&®↓ c-ILD to Boehringer Ingelheim Pharmac£÷€euticals Inc.The FDA, a★®n agency within the U.S. Department of Health anδ‌ ∞d Human Services, prote♠≈→cts the public health by asγ↕$★suring the safety, e•βffectiveness, and security of human and vete∑≠ rinary drugs, vaccines and other¶&₹£ biological products for human use, an₹σΩ₹d medical devices. T€•he agency also is resp<♦→onsible for the safety and security of §±'>our nation's food supply, cosmetics, diet§± ary supplements, products that give off elec¶ tronic radiation, and for regulat™​↓'ing tobacco products.Media Inq÷≤<♣uiries: Nathan Arnold, 301-796-6248, natγ★≥han.arnold@fda.hhs.govConsumer Inqγ &uiries: 888-INFO-FDA2019 Asia-pacific$✘ pharma IP Leader Summit: http://en₩↓.zenseegroup.com/p/510934/ will©®γ§ be held in Beijing &nbs€∞$φp;on November 14-15, and will attra"'Ωφct more than 500 industry expert↔$±s from domestic and foreign phar±¥maceutical companies, biotechnology companiesε∑™÷, governments, associations, law firms, inte<✔δπllectual property agents and other comε¶<panies to attend.Official registr€↔ ation and consultation chan↔σnels:Contact：AnnPhone: 021-65650305Email：Marke ∞↕©ting@zenseegroup.comhttp://e↑π∑♦n.zenseegroup.com/p/51093✔♠<4/