FDA Advisory Committee Recommends Approval of Ofev® for the Treatment of Systemic Sclerosis Associated ILD

• FDA's Arthritis Advisory Committee recommended (10-7 vote) to approve Ofev® (nintedanib) for the treatment of systemic sclerosis associated ILD (SSc-ILD)
• ILD is the leading cause of early death in patients with systemic sclerosis (SSc), also known as scleroderma
• If approved, Ofev® (nintedanib) would be the first medicine approved in the US for the treatment of these patients

RIDGEFIELD, Conn., July 25, 2019 /PRNewswire/ -- Boehringer Ingelheim today announced that the FDA's Arthritis Advisory Committee recommended (10-7 vote) to approve Ofev® (nintedanib) for the treatment of systemic sclerosis associated interstitial lung disease, or SSc-ILD.

"The committee's recommendation brings nintedanib one step closer to becoming available to patients who suffer from the devastating impact of systemic sclerosis associated interstitial lung disease," said Thomas Seck, M.D., senior vice president, Medicine and Regulatory Affairs, Boehringer Ingelheim. "Based on the strength of the data presented, and the positive recommendation by the committee, we are hopeful that the FDA will approve nintedanib as a treatment option for patients with SSc-ILD. If approved, nintedanib would be the first treatment approved in the US for these patients."

Systemic sclerosis, also known as scleroderma, is a rare disease characterized by thickening and scarring of connective tissue throughout the body. Fibrosis, the hallmark of the disease, can affect the skin and internal organs, including the lungs. Interstitial lung disease or ILD, one of the most frequent disease manifestations, can be debilitating and may become life-threatening. Approximately 25 percent of patients develop significant pulmonary involvement within three years of diagnosis. ILD is the leading cause of death among people with systemic sclerosis.

The recommendation by the committee was based on results of the Phase III SENSCIS® trial, the largest randomized controlled study to be conducted in patients with SSc-ILD, a disease for which there are currently no FDA-approved treatments. Results showed that nintedanib slowed the loss of pulmonary function by 44% (41 mL/year) in patients with SSc-ILD relative to placebo, as measured by forced vital capacity (FVC) over a 52- week period.

Professor Toby Maher, M.D, Ph.D, Imperial College, London, said: "The committee's vote to recommend nintedanib for approval reaffirms the treatment effect observed in the Phase III study as clinically important in preserving lung function in this at-risk patient population. If approved, nintedanib will be a welcome treatment option to offer patients with SSc-ILD, a disease with a high rate of mortality."

Study results formed the basis of the supplemental new drug application filed with the FDA and EMA in the first quarter of 2019. In May, the FDA granted priority review to the application for nintedanib in SSc-ILD.

About the study
SENSCIS, a Phase III double-blind, randomized, placebo-controlled trial, involved 576 patients from 194 trial sites across 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 mL with nintedanib versus -93.3 mL with placebo (absolute difference 41.0mL/year [95% CI 2.9, 79.0]; p=0.04). This corresponds to a 44% reduction in the rate of lung function decline, similar to the results from the Phase III INPULSIS® trials in IPF. FVC is an established measurement of lung function. As SSc-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%).

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:

• liver problems
• heart problems
• a history of blood clots
• a bleeding problem or a family history of a bleeding problem
• had recent surgery in your stomach (abdominal) area
• any other medical conditions.

Tell your doctor if you:

• are pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not known if Ofev passes into your breast milk. You should not breastfeed while taking Ofev.
• are a smoker. You should stop smoking prior to taking Ofev and avoid smoking during treatment.

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.
• Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements.
• Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck or jaw, or shortness of breath.
• Stroke. Symptoms of a stroke may include numbness or weakness on 1 side of your body, trouble talking, headache, or dizziness.
• Bleeding problems. Ofev may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, or wounds that do not heal and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
• Tear in your stomach or intestinal wall (perforation). Ofev may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.

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.

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.

Contact:
Boehringer Ingelheim
Pharmaceuticals, Inc.
Name: Paul Wynn
Public Relations
Phone: 203-482-4512
Email: paul.wynn@boehringer-ingelheim.com

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