MaaT’s FDA Woes Highlight Rocky Regulatory Path For Microbiome-Based Therapies
Clinical Hold Remains On Graft-Versus Host Disease Drug
The French firm's lead microbiome therapy has been on clinical hold in the US for a year and continuing concerns about MaaT's 'pooling' approach (mixing donations from multiple donors) suggests the wait to restart trials will not be a short one.
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When the Swiss company files RBX2660 in the US later this year to reduce recurrences of Clostridioides difficile infection, it will be the first time any firm has tried to get a non-antibiotic product approved to address an infectious disease. Ferring president Per Falk tells Scrip about the 35-year journey to get to this stage and why standardization is key when it comes to microbiome-based therapy.
The promise of microbiome-based therapeutics to treat a variety of diseases has become a hot topic and the first to get to market will be targeting Clostridioides difficile infection. Ferring and its subsidiary Rebiotix are in pole position.
Discussion of the launch trajectory for the twice-yearly cholesterol therapy dominated the marketing portion of Novartis’s investor event and the firm is confident the foundations have been laid to push strong sales growth by the second half of next year.