Boehringer Ingelheim shares update on supplemental New Drug Application for OFEV® (nintedanib) for children and adolescents

Ridgefield, Connecticut, Tue, 03/12/2024 - 08:00

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental New Drug Application (sNDA) for OFEV^® (nintedanib) for the treatment of fibrosing interstitial lung disease (ILD) in children and adolescents between 6 to 17 years of age. The letter stated that the FDA could not approve the application in its current form.

“Childhood interstitial lung diseases can have a significant impact on patients and their families,” said Leticia Orsatti, M.D., Vice President, Clinical Development and Medical Affairs, Boehringer Ingelheim. “While we were hopeful to potentially bring forward a treatment option for this vulnerable patient population, Boehringer Ingelheim remains committed to our ongoing research to support people across generations living with pulmonary fibrosis.”

The FDA’s letter has no impact on InPedILD™-ON (NCT05285982), an open-label study to evaluate the long-term safety of nintedanib in children and adolescents with ILD. A regulatory application is still under review by the European Medicines Agency.

What is OFEV?

OFEV is a prescription medicine used:
- to treat adults with a lung disease called idiopathic pulmonary fibrosis (IPF).
- to treat adults with a long lasting (chronic) interstitial lung disease in which lung fibrosis continues to worsen (progress).
- to slow the rate of decline in lung function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
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?

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 highly effective birth control at the start of treatment, during treatment, and for at least 3 months after your last dose. Talk with your doctor about what birth control method is right for you during this time. Birth control pills may not work as well in women having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these problems, talk with your doctor about what highly effective birth control method is right for you. If you become pregnant or think you are 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 about all of your medical conditions, including 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.

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, and 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 to check how well your liver is working before starting and 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 one 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, 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.
Increased protein in your urine (proteinuria). OFEV may increase your chances of having protein in your urine. Tell your doctor if you have any signs and symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs, or feet, or sudden weight gain.

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/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information, including Patient Information.

CL-OF-100056 01.18.2022

About Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that transform lives, today and for generations to come. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term, sustainable perspective. More than 53,000 employees serve over 130 markets in the two business units Human Pharma and Animal Health. Learn more at www.boehringer-ingelheim.com/us/.