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 treatment of SSc-ILD. Panelists also voted 10-7 that the data...
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