Gattex Goes To Advisory Panel With Positive Confirmatory Trial Data
This article was originally published in The Pink Sheet Daily
Clinical data for teduglutide, which goes before the Gastrointestinal Drugs Advisory Committee Oct. 16 as the first drug for treating short bowel syndrome, includes positive results from a confirmatory trial and mixed results from the initial study.
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In briefing documents released ahead of the Oct. 16 Gastrointestinal Drugs Advisory Committee review, FDA suggests there is room for improvement in NPS’ communication plan for the short bowel syndrome treatment teduglutide to convey serious risks about malignancy and polyp growth and GI obstruction.
The rare-disease focused company is putting commercial plans in place for its first drug, Gattex, which could launch early next year, and is preparing to file a second NDA in mid-2013, later than expected due to requirements from FDA.
The EU's CHMP gave positive opinions on three new products – Novartis' glycopyrronium, AstraZeneca's ceftaroline and Takeda's teduglutide – and on a major new indication for Novartis’ everolimus (Afinitor), after its meeting on June 18-21.