FDA Approves Boehringer Ingelheim’s Ofev for Wider Use in Lung Disease


The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s Ofev (nintedanib) for patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype. It is the first drug to be approved in the U.S. for patients with this type of lung disease.

The drug was originally approved to treat idiopathic pulmonary fibrosis (IPF) in 2014. Last year it was approved for extended indications with ILD caused by systemic sclerosis (SSC-ILD), which is a rare autoimmune disease affecting about 100,000 people in the U.S.

Chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype is a group of fibrotic lung disease—fibrosis refers to scarring—caused by different diseases, including autoimmune ILD, hypersensitivity pneumonitis and idiopathic nonspecific interstitial pneumonia. These diseases are all marked by lung scarring and rapid progression of the disease, which is tested by way of lung function tests, symptoms and potentially imaging. It leads to breathlessness and respiratory failure. It can be both debilitating and life-threatening.

“The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now.”

The drug’s safety and effectiveness were studied in a randomized, double-blind, placebo-controlled trial of 663 adult patients with a mean age of 66 years. The primary test for effectiveness was forced vital capacity, a test for lung function. In the year-long trial, patients received 150 mg of Ofev twice a day or a placebo. After the 52 weeks, people taking Ofev had less lung function decline compared to the placebo cohort.

The most common side effects were diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache and weight loss. The drug is not recommended for patients with moderate or severe liver problems.

The new approval applies to about 18% to 32% of patients with about 200 separate diseases, including “unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, Sjogren’s syndrome, coal workers pneumoconiosis and idiopathic forms of interstitial pneumonias,” stated Boehringer Ingelheim.

At its most severe, ILD can decrease life expectancy by three to five years.

Ofev is a blockbuster drug and grew almost 29% to reach 1.1 billion euros in 2018 for IPF. The 2019 financial figures haven’t been reported yet, but in the first half of the year sales grew 22% to 677 million euros.

Although Ofev is considered Boehringer’s flagship product for its fibrosis franchise, the company is making significant investments in the category. Earlier this year it signed a multi-billion-euro deal with Enleofen for IL-11 inhibitors for fibrotic disease of the lungs, liver and other organs. Previous deals were signed with Bridge Biotherapeutics for an Ofev follow-up and with South Korea’s Yuhan Corporation on a first-in-class dual agonist for the treatment of non-alcoholic steatohepatitis (NASH) and related liver diseases.

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