Le Lézard
Classified in: Health
Subject: SVY

Phase III study showed Ofev® slows the loss of pulmonary function in people living with systemic sclerosis associated ILD


RIDGEFIELD, Conn., May 20, 2019 /PRNewswire/ -- Boehringer Ingelheim today announced that the SENSCIS® trial met its primary endpoint: reduction in the annual rate of decline in forced vital capacity (FVC) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). Results showed that Ofev® (nintedanib) slows the loss of pulmonary function by 44% in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks. These new data were published today in the New England Journal of Medicine (NEJM) and presented to the medical community at the American Thoracic Society (ATS) International Conference in Dallas.

Boehringer Ingelheim (PRNewsFoto/Boehringer Ingelheim)

SENSCIS is the largest randomized controlled trial to be conducted in patients with SSc-ILD, a disease for which there are currently no approved treatments. Results demonstrated that nintedanib was generally well-tolerated with the most common side effect being diarrhea. The safety and tolerability profile in SSc-ILD patients was similar to that previously observed in idiopathic pulmonary fibrosis (IPF) patients treated with nintedanib.

"These study results are welcome news for doctors and their patients because lung fibrosis, which results in shortness of breath and persistent coughing, is a devastating and often fatal consequence of systemic sclerosis," said study investigator Kristin Highland, M.D., pulmonologist with the Cleveland Clinic.

Results from this study form the basis of the application for regulatory approval of nintedanib in SSc-ILD that was filed with the FDA and EMA by Boehringer Ingelheim in the first quarter of 2019. The FDA recently granted priority review to the supplemental for nintedanib in SSc-ILD. The regulatory submissions are part of the company's ongoing commitment to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need. Nintedanib, marketed as Ofev, is already approved in more than 70 countries for the treatment of IPF.

"The study provides positive evidence that nintedanib significantly slows the progression of lung function decline for those living with systemic sclerosis who are diagnosed with interstitial lung disease," said Thomas Leonard, Ph.D., executive director, Clinical Development and Medical Affairs, Specialty Care, Boehringer Ingelheim. "Boehringer Ingelheim is pleased that the FDA has recognized the urgency to bring a new treatment to patients by designating the application as a priority review."

About the results
SENSCIS, a Phase III double-blind, randomized, placebo-controlled trial, involved 576 patients across more than 32 countries. The primary endpoint was the annual rate of decline in FVC in mL over 52 weeks. At the end of the 52-week trial, patients receiving nintedanib had an adjusted annual rate of decline in FVC (mL/year) of -52.4 with nintedanib versus -93.3 with placebo (absolute difference 41.0mL/year [95% CI 2.9, 79.0]; p=0.04). This corresponds to a relative difference of 44% reduction in lung function decline, similar to the results from the Phase III INPULSIS® trials in IPF. FVC is an established measurement of lung function. As ILD progresses, lung function gradually and irreversibly deteriorates.

There was no difference between groups for secondary endpoints, skin thickness and quality of life, as measured at week 52 by the modified Rodnan Skin Score (mRSS) and the St. George's Respiratory Questionnaire (SGRQ), respectively.

In the study, the percentage of total adverse events were similar in both groups. A higher incidence of diarrhea, the most common side effect, was reported in the nintedanib group (75.7%) versus the placebo group (31.6%).

About systemic sclerosis
Systemic sclerosis, also known as scleroderma, is a rare disease characterized by thickening and scarring of connective tissue throughout the body. It is estimated that up to 2.5 million people worldwide have systemic sclerosis, including approximately 100,000 people in the United States. The disease can cause scarring of the skin, lungs (interstitial lung disease), heart and kidneys, which can be debilitating and may become life-threatening. Approximately 25 percent of patients develop significant pulmonary involvement within three years of diagnosis. Lung involvement is the leading cause of death among people with systemic sclerosis.

What is Ofev?
Ofev is a prescription medicine used to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF). It is not known if Ofev is safe and effective in children.

Important Safety Information

What is the most important information I should know about Ofev (nintedanib)?

Ofev can cause harm, birth defects or death to an unborn baby. Women should not become pregnant while taking Ofev. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use birth control during and for at least 3 months after your last dose. If you become pregnant while taking Ofev, tell your doctor right away.

What should I tell my doctor before using Ofev?

Before you take Ofev, tell your doctor if you have:

Tell your doctor if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements such as St. John's wort.

What are the possible side effects of Ofev?

Ofev may cause serious side effects.

TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:

Liver problems. Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests regularly to check how well your liver is working during your treatment with Ofev.

The most common side effects of Ofev are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.

These are not all the possible side effects of Ofev. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch or call 1-800-FDA-1088.

For full prescribing information, including patient information, please visit www.Ofev.com.

About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.

Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned, and today our goal is to improve the lives of humans and animals through its three business areas: human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.

Boehringer Ingelheim concentrates on developing innovative therapies that can improve and extend patients' lives. As a research-driven pharmaceutical company, it plans in generations for long-term success. Its research efforts are focused on diseases with high, unmet medical need. In animal health, the company stands for advanced prevention.

In 2018, Boehringer Ingelheim achieved net sales of around $20.7 billion (17.5 billion euros). R&D expenditure of almost $3.7 billion (3.2 billion euros) corresponded to 18.1 per cent of net sales.

Boehringer Ingelheim is committed to improving lives and strengthening our communities.  Please visit www.boehringer-ingelheim.us/csr to learn more about Corporate Social Responsibility initiatives.

For more information, please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.

SOURCE Boehringer Ingelheim Pharmaceuticals


These press releases may also interest you

at 00:25
Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences," HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial...

28 mar 2024
The report titled "Central Lab Market by Service Type (Anatomic Pathology/Histology, Biomarker Services, Genetic Services), Phase (Phase 1, Phase 2, Phase 3), Therapeutic Area, End-use - Global Forecast 2024-2030" is now available on...

28 mar 2024
The report titled "Personalized Nutrition Market by Measurement Type (Active Measurement, Standard Measurement), Application (Indication-based, Standard Supplements), Distribution Channel, End-Use - Global Forecast 2024-2030" is now available on...

28 mar 2024
The report titled "Carbon Dioxide Incubator Market by Product (Air Jacketed CO2 Incubators, Direct Heat CO2 Incubators, Water Jacketed CO2 Incubators), Capacity (100-200 Litre, Above 200 Litre, Below 100 Litre), Application, End User - Global...

28 mar 2024
The "Global Clinical In Vitro Diagnostic Medical Laboratory Services Market: Strategy & Trends with Volume & Price Forecasts by Chemistry, Hematology, Microbiology, Pathology, Covid-19, and Molecular Dx by Country. Updated with Impact of COVID-19"...

28 mar 2024
The "Molecular Diagnostics at the Point of Care. By Application, Technology, Place, Product and by Country. With Executive Guides and Customization 2023 - 2027 " report has been added to  ResearchAndMarkets.com's offering. Infectious disease Dx is...



News published on and distributed by: