FDA Advisory Committee Recommends Ofev Approval for Treatment of Interstitial Lung Disease

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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TLY012 orphan drug status

The Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) has recommended — via a 10-7 vote — the approval of Ofev (nintedanib) for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Ofev, marketed by Boehringer Ingelheim, is under investigation for its ability to potentially treat interstitial lung disease (ILD). In ILD, the tissue in and around the lung air sacs — called the interstitium —- becomes inflamed and fibrotic, or scarred. The therapy works by blocking growth factor receptors that are involved in fibrosis.

The medication was previously designated an orphan drug by both the FDA and the European Medicines Agency (EMA) for the treatment of scleroderma, as well as the associated ILD. Ofev also is already approved as a treatment for idiopathic pulmonary fibrosis in more than 70 countries, including the U.S.

In early 2019, a new drug application was filed to both agencies for regulatory approval for treating SSc-ILD. In May, the FDA granted Ofev priority review, which means the agency’s goal is to take action on an application within 6 months.

The decision of the FDA’s advisory committee was based largely on results from the SENSCIS trial (NCT02597933), in which 576 SSc-ILD patients were treated with either Ofev or a placebo for a year. Ofev treatment was found to significantly slow the decline in lung function (44% less decline in forced vital capacity) in these patients.

“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,” Thomas Seck, MD, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, said in a press release.

“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,” Seck said.

“If approved, nintedanib would be the first treatment approved in the U.S. for these patients,” he added.

According to Boehringer, ILD is the leading cause of death among people with SSc, with about 25% of patients developing ILD within three years of SSc diagnosis.

“The committee’s vote to recommend nintedanib for approval reaffirms the treatment effect observed in the Phase 3 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,” said Toby Maher, MD, PhD, a professor at Imperial College London, who studies lung disease.