biospaceMarch 20, 2018
Tag: Boehringer Ingelheim , FDA
Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD). The FDA's Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner.
This designation is based on Boehringer Ingelheim's Investigational New Drug application (IND) of nintedanib for the treatment of SSc-ILD and the anticipated efficacy and safety data from SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled global Phase III trial. This pivotal study is fully enrolled, including more than 520 patients from 32 countries.
"This Fast Track designation is an encouraging step in our ongoing research and commitment to advancing care of those with systemic sclerosis with interstitial lung disease," said Christopher Corsico, M.D., Chief Medical Officer, Boehringer Ingelheim. "It is critical that we address the significant unmet medical need of those living with this disease and we are looking forward to working with the FDA to advance the development of this potential therapy."
Robert Riggs, Chief Executive Officer of the Scleroderma Foundation, added: "There have been no FDA-approved treatment options for scleroderma with lung involvement and very few drugs assessed in clinical trials for a devastating reality for people living with the disease."
Systemic sclerosis, also known as scleroderma, is a rare disease characterized by the thickening and scarring of connective tissue of multiple organs in the body, typically affecting women between ages 25 and 55. Most people with the disease will develop some degree of lung scarring, or interstitial lung disease (ILD), which is the leading cause of death among people with systemic sclerosis.
Nintedanib, which is marketed as Ofev®, is approved for a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSC-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim is evaluating the impact of nintedanib on SSC-ILD.
About SENSCIS™
SENSCIS™ is a randomized, double-blind, placebo-controlled study (NCT 02597933)evaluating the efficacy and safety of nintedanib 150 mg twice daily over 52 weeks up to a maximum of 100 weeks in people with SSc-ILD. The primary endpoint is the annual rate of decline in forced vital capacity (FVC), a measure of lung disease progression. Key secondary endpoints include the absolute change from baseline in the modified Rodnan Skin Score (mRSS), which is an evaluation of people's skin thickness, and the absolute change from baseline in the Saint George´s Respiratory Questionnaire (SGRQ) total score, which measures the health-related quality of life of people with lung diseases.
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:
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.
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, 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 creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.
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