Boehringer Avoids Further Efficacy Study Of Ofev In SSc-ILD With Full Approval, No Post-Marketing Commitments

 
• By Michael Cipriano
  
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Despite concerns from members of US FDA's Arthritis Advisory Committee that the efficacy profile of Boehringer Ingelheim's Ofev needs more study in the SSc-ILD indication, the company does not have any such postmarketing requirements or commitments.

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The FDA approved Ofev for SSc-ILD, a rare lung disease.

Although several members of the US FDA's Arthritis Advisory Committee wanted to see additional data characterizing the efficacy profile of Boehringer Ingelheim GmbH's Ofev (nintedanib) in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD), it looks like the company will skate by without having to conduct any such trials in the postmarket setting.

The US Food and Drug Administration specifically granted a full approval to Ofev on 6 September for a supplemental indication...

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