The U.S. Food and Drug Administrat<♠ion today approved Ofev (nintedanib)♦" capsules to slow the rate of ​&∞decline in pulmonary functio↔ λ±n in adults with intersti ♦tial lung disease associated with system↕₹​ic sclerosis or scleroderma, called SSc-ILD. It ✔​£βis the first FDA-approved treatment for this ≥←rare lung condition."Pat' ients suffering from scleroderma n©♣eed effective therapies, and the FD  A supports the efforts of drug comp₽β ‌anies that are designing and ∞✔δconducting the clinical trials necessary t↑λo bring treatment options to scleroderma patientsσ±σ," said Nikolay Nikolov,↑£© M.D., associate director for Rheumatology o↕∏±¶f the Division of Pulmonγ ary, Allergy, and Rheum↑≠∑αatology Products in the F‍$DA's Center for Drug Evaluatioφ≤n and Research. "Ninteαλdanib is now a treatment option ★®to slow the rate of d±∏↑ecline in pulmonary function in patients wβ←ho have interstitial lung disease from sc×↔§leroderma."Scleroder✔™♣ma is a rare disease that causes tis>γγsue throughout the body, including the lungs a≈™nd other organs, to thicken and s←↔‌car. Interstitial lu&"♦"ng disease or ILD is a condition∞α→α affecting the interstitium, wh♠‌£☆ich is part of the lung's st¥δructure, and is one of the most common disease maαβ÷​nifestations of sclerderma. SSc-ILD is a progress ™ive lung disease in which lung function d↔¥eclines over time, a✘"nd it can be debilitating and life-tπ¥™hreatening. ILD is th$∞φe leading cause of dea‌∞♣th among people with sclero®£‍←derma, typically resulti‍×≠♥ng from a loss of pulmonary∏‍ function that occurs  ∑when the lungs cannot supply enough oxyge↓δ↓ n to the heart. Approxim¶ σσately 100,000 individual₽∞s in the United States have scleroderma, and ap→÷₹↕proximately half of scleroderma pat↑" §ients have SSc-ILD.The effectiveness of Ofev to t♦₩'reat SSc-ILD was studied in a randomized, double-‌§blind, placebo-controlled tria<×±εl of 576 patients ages↓π> 20-79 with the disease. Patients received₹¶ treatment for 52 weeks, with so <±εme patients treated up <&γto 100 weeks. The primary test for eff±δicacy measured the forced®₩∞  vital capacity, or FVC, which is a m♠★easure of lung function, defined♦  as the amount of air tha☆•σt can be forcibly exhaled from the lungs after taλ king the deepest breath possible. Those who to ®&ok Ofev had less lung function de¶✘ ✘cline compared to those on placebo.The↑↓ overall safety profile observed in the Ofevσγ ® treatment group was™¥φ consistent with the known safety prof±₹××ile of the therapy. The most fr &$™equent serious adverse event reported​δ≥ in patients treated →®with Ofev was pneumonia (2.8% Ofev vs. 0.3¥✘% placebo). Adverse reac∞®✔tions leading to permanent dose reductions werδ¶e reported in 34% of Ofev-treated patients cβ≈δ×ompared to 4% of placebo-tr₩↑eated patients. Diarrhea was the mo ¶♦£st frequent adverse reaction that <ββled to permanent dose reduction in patients tr©≠‌eated with Ofev.The prescribing information fo↑₹™ r Ofev includes warnings for paε₹<tients with moderate↓£ or severe hepatic (liver) impairment, thos→φ'e with elevated liver enzymes and drug-induced ∑γ₩liver injury and patients with ga<×strointestinal disorders. Ofev may also cause e↑<mbryo-fetal toxicity that can res₽↕&ult in fetal harm, arterial thrombo×σembolic events (blood clots), b¥±®leeding and gastrointestinal pe♠∞☆rforation. P-gp and CYP3A4 ₩÷ inhibitors may increase nintedanib exposure, an↔§€♥d patients taking these inhibitors should be ₹&closely monitored for tolerability of Ofev. Co♠®mmon side effects noted with ∞↑Ofev include diarrhea,♥₩ nausea, abdominal pain, vomiting, liver enzyme ↕↔elevation, decreased appetite, head₹₹→ache, weight loss and•λ hypertension (high b§®Ω≥lood pressure).Ofev was originally ± ‍₽approved in 2014 for adult patients with idiσ↕opathic pulmonary fibrosis (IPF), which is±‍ another interstitial lung conditio€÷n.Ofev received Priority Review designat≠↕&ion, under which the FDA's goal&ε€‌ is to take action on an ap≥ ≈plication within six months where≤©₩ the agency determines that¶∞↕Ω the drug, if approved, would significant✘‍&ly improve the safety or effectiven±₩>φess of treating, diagnosing or preventing a seri₽‍ous condition. Ofev also received Orpha☆∏‍n Drug designation, which ♠φprovides incentives t "₽o assist and encourage the development of d™$rugs for rare diseases.The FDA gran£✔ted the approval of Oγγfev to treat SSc-ILD to×←≠≠ Boehringer Ingelheim Pharmaceuticals In→•c.The FDA, an agency within₽↑←β the U.S. Department ≤​of Health and Human Services, protects←γ the public health by assuring the safety≤‌★, effectiveness, and security of human and↑φ≥ veterinary drugs, vacc≠ ines and other biological products fo∑☆r human use, and medical devices. The agenc'¶★y also is responsible for the safety and secur↓σσity of our nation's food supply, cosmetics®' , dietary supplements, products that giveΩ♣₹  off electronic radiation, and for regulating←§✔≥ tobacco products.Media Inquiφ↓ries: Nathan Arnold, 301-796-α ♥↓6248, nathan.arnold@fda.hhs.govConsu↑ε ♠mer Inquiries: 888-INFO-FDA2019 Asia-p£±>"acific pharma IP Leader Summit: http://en.β'•zenseegroup.com/p/510934/ will be h★≠&<eld in Beijing  ₽♥;on November 14-15, λ₩and will attract more than 500 industry expe'¥rts from domestic and f←♥oreign pharmaceutical companies, biotechnology βλcompanies, governments, associati​≠≈ons, law firms, intellectual property agents and≈<€ other companies to at≥βtend.Official registration aφ♣×nd consultation channels:Contact：AnnPh< σone: 021-65650305Email：Marketing@zenseeg←δ∑βroup.comhttp://en.zenseegroup.com/p/510934/