FDA
22nd August 2019

FDA Panel Recommends Approval of Nintedanib for Systemic Sclerosis

The Arthritis Advisory Committee (AAC) met on July 25th to review the supplemental New Drug Application.

FDA Panel Recommends Approval of Nintedanib for Systemic Sclerosis

The Arthritis Advisory Committee (AAC) met on July 25th to review the supplemental New Drug Application (sNDA) 205832 for nintedanib capsules by the applicant: Boehringer Ingelheim.  The panel evaluated the proposed indication for treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Systemic Sclerosis (SSc) is a rare, multisystem connective tissue disease. It creates microvascular damage and fibrosis of the skin and internal organs, resulting in cardiac and pulmonary complications. Interstitial lung disease (ILD) is a common manifestation and is the leading cause of death in SSc. It currently affects around 100,000 people in the United States. There are no FDA-approved therapies, so treatment is typically guided by expert opinion.

Nintedanib, brand name Ofev, is an oral capsule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs), blocking numerous pro-fibrotic pathways implicated in pulmonary fibrosis. Nintedanib is approved in more than 70 countries. The safety and efficacy are supported by a clinical program which consists of three phase 3 studies: INPULSIS-1, INPULSIS-2, and SENSCIS. SENSICS is the first placebo-controlled trial in SSc-ILD that reached the primary endpoint of slowing forced vital capacity (FVC) decline, which is a marker of ILD progression.

This meeting was comprised of two discussion questions and three voting questions. The chief voting question discussed to recommend the approval of nintedanib, 150mg twice daily, for the treatment of SSc-ILD. The committee voted 10 (YES) to 7 (NO). The panelists who voted “YES” were optimistic about nintendanib’s efficacy in patients with SSc-ILD based on the primary endpoint result from SENSCIS. The panelists who voted “NO” emphasized the effect size was small and were concerned about the lack of statistical significance for the secondary endpoints related to quality-of-life and reduction of skin fibrosis associated with SSc.

The agency is not obligated to follow its panels’ recommendation, but normally does so.

The sNDA is under FDA priority review and is currently pending on date for decision.

 

ISS has almost two decades of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

This post was authored by Sharon Christian. Sharon is a summer intern at ISS and a graduate student at Rutgers University Ernest Mario School of Pharmacy.

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