Ofev FDA approval recommendation: The US FDA’s Arthritis Advisory Committee has recommended approval of Boehringer Ingelheim’s kinase inhibitor Ofev (nintedanib) for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD).
The committee’s Ofev FDA approval recommendation was driven by the findings of the phase 3 SENSCIS trial, held in patients with SSc-ILD, a disease for which currently there are no FDA-approved treatments.
Results from the late-stage trial demonstrated that nintedanib slowed the loss of pulmonary function by 44% in patients with SSc-ILD, compared to placebo, as measured by forced vital capacity (FVC) during a 52-week treatment period.
Toby Maher of Imperial College, London, commenting on Ofev FDA approval recommendation, 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.”
Ofev is indicated for the treatment of idiopathic pulmonary fibrosis (IPF), a type of lung disease. Ofev FDA approval for IPF was granted in October 2014. As of now, the safety and effectiveness of Ofev in children are yet to be established.
Commenting on Ofev FDA approval recommendation, Thomas Seck – senior vice president of Boehringer Ingelheim Medicine and Regulatory Affairs said: “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.
“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.”
The results of the phase 3 SENSCIS trial were used as a basis by Boehringer Ingelheim for filing its supplemental new drug application with the FDA and European Medical Agency (EMA) in Q1 2019. In May 2019, the German pharma company secured priority review for Ofev in SSc-ILD.
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