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Sollpura's Future After No Vote From Panel Might Include More Trials, Adult Indication

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's Gastrointestinal Drugs Advisory Committee says in lopsided votes that Lilly's exocrine pancreatic insufficiency drug candidate Sollpura (liprotamase) lacks proof of efficacy.

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The troubles that Alnara Pharmaceuticals has had with its application for Sollpura (liprotamase) for exocrine pancreatic insufficiency signal the challenges that developers of other drugs in crowded classes may face at FDA.

Can You Still Use Surrogate Markers In A Crowded Drug Class? Sollpura Panel Recommends BMI, Weight Endpoints

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