Boehringer Ingelheim Ofev Is Approved By The European Union For The Treatment Of Systemic Sclerosis-related Interstitial Lung Disease (SSc-ILD)!

- Mar 18, 2020-

German pharmaceutical giant Boehringer Ingelheim recently announced that the European Commission (EC) has approved the oral small molecule tyrosine kinase inhibitor Ofev (nintedanib, Nidanib, 150mg capsules) for the treatment of systemic sclerosis Adult patients with related interstitial lung disease (SSc-ILD). It is worth mentioning that Ofev is the first and only drug approved for the treatment of SSc-ILD. In the largest SSc-ILD phase III clinical study to date, Ofev significantly delayed the progression of patients' lung function decline compared to placebo.

Ofev was the first to be approved by the US FDA in September 2019, becoming the first and only drug that can slow down the decline of lung function in SSc-ILD adult patients. At present, Ofev has been approved in 15 countries including Canada, Japan, and Brazil for the treatment of adult patients with SSc-ILD. Previously, Ofev has been approved for the treatment of patients with idiopathic pulmonary fibrosis (IPF) in more than 70 countries around the world and has been shown to be slowed by reducing the annual rate of decline in lung function (measured by forced vital capacity [FVC]) IPF progress.

Systemic sclerosis (SSc), commonly known as "scleroderma", is a disfiguring, disabling, potentially fatal, rare autoimmune disease characterized by thickening and scarring of connective tissue throughout the body. It is estimated that this disease affects 2.5 million people worldwide. Fibrosis (scarring) is a hallmark feature of the disease, which can affect the skin and various organs in the body, including the lung, heart, digestive tract, kidney, etc., and may cause life-threatening complications. When SSc affects the lungs, it can cause interstitial lung disease (ILD), called SSc-ILD, which is a progressive lung disease that decreases lung function over time. ILD is one of the most common manifestations of SSc. About 25% of patients have obvious lung involvement within 3 years after diagnosis. ILD is also the main cause of death in SSc patients, accounting for approximately 35% of SSc-related deaths. The incidence of SSc-ILD in women is four times that of men, and the age of onset is usually 25-55 years old.

Peter Fang, senior vice president and regional head of inflammation treatment at Boehringer Ingelheim, said: "This approval is a real breakthrough in the treatment of SSc-ILD. The disease is a life-changing disease and once pulmonary fibrosis occurs, it cannot be The reversal will have a devastating impact on the patient's life and daily activities. Ofev is the first and only drug approved for the treatment of SSc-ILD, which will solve the major unmet medical needs in this field. We are committed to This approval to improve the lives of patients with pulmonary fibrosis is a milestone achieved to help slow the progression of this rare, life-changing disease. "

This new indication approval is based on data from the Phase III clinical study SENSCIS ((NCT02597933), which is the largest SSc-ILD study to date. The study is a double-blind, randomized, placebo-controlled study involving 32 576 patients from 194 trials in each country. During the study, patients were randomly assigned to receive Orev twice daily (dose 150mg) or placebo. The primary endpoint was the year of forced vital capacity (FVC) in SSc-ILD patients Decline rate.

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The results showed that after one year (52 weeks) of treatment, measured by FVC, Ofev significantly reduced the decline in lung function in SSc-ILD patients by 44% compared with placebo (FVC adjusted annual decline rate: -52.4 ml / Year vs -93.3 ml / year, absolute difference: 41.0 ml / year [95% CI: 2.9-79.0], p = 0.04). In this study, the overall safety profile observed in the Ofev treatment group was consistent with the known safety profile of the drug in patients with idiopathic pulmonary fibrosis (IPF). Among patients receiving Ofev, the most common serious adverse event was pneumonia (2.8% in the Ofev group vs 0.3% in the placebo group). 34% of Ofev-treated patients experienced adverse reactions that resulted in permanent dose reduction, compared with 4% in the placebo group. Diarrhea is the most common adverse reaction leading to a permanent dose reduction of Ofev.

Ofev's prescription information includes warning messages for patients with moderate or severe liver injury, patients with elevated liver enzymes and drug-induced liver injury, and patients with gastrointestinal disorders. Ofev may also cause embryo-fetal toxicity leading to fetal injury, arterial thromboembolic events, bleeding, and gastrointestinal perforation. P-gp and CYP3A4 inhibitors may increase Ofev's exposure, and patients taking these inhibitors should closely monitor Ofev's tolerance. Common side effects of Ofev include diarrhea, nausea, abdominal pain, vomiting, increased liver enzymes, decreased appetite, headache, weight loss, and high blood pressure (hypertension). (