The US Food and Drug Administration's Arthritis Advisory Committee narrowly supported approving Boehringer Ingelheim GmbH's Ofev (nintedanib) for the supplemental indication of systemic sclerosis associated interstitial lung disease (SSc-ILD), leaving the agency to ponder whether it should require more data in the pre- or postapproval phase.
The committee specifically voted 10-7 to recommend backing Ofev at the proposed dose of 150 mg twice daily for the...