EMA recommends nintedanib approval for SSc-ILD

medwireNews: The EMA’s Committee for Medicinal Products for Human Use has recommended expanding the indication for nintedanib to include systemic sclerosis (SSc)-associated interstitial lung disease (ILD).

The tyrosine kinase inhibitor, previously approved for the treatment of idiopathic pulmonary fibrosis, was designated an orphan medicine, and underwent accelerated assessment for SSc-ILD due to being “a medicine of major interest for public health.”

This announcement follows US approval of the tyrosine kinase inhibitor for SSc-ILD in 2019.

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