Roche Reviewing Next Steps For Lebrikizumab After Mixed Phase III Data
This article was originally published in The Pink Sheet Daily
One of two identical Phase III trials testing the IL-13 blocker in severe asthma patients met its primary endpoint, while the other failed.
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Dermira hopes to move into Phase III quickly with IL-13 inhibitor lebrikizumab, looking at monthly dosing in the maintenance setting. Efficacy in Phase IIb appears similar to Sanofi/Regeneron’s Dupixent.
Dermira will focus on developing the IL-13 inhibitor in atopic dermatitis, where it sees an opportunity for potential dosing and efficacy benefits. Roche had focused on respiratory disease, with mixed results.
UK HTA body NICE has called for clarifications and updated analyses in draft guidance on Teva’s MAb biologic Cinqaero, a decision that may give heart to potential competitors in the race to dominate the eosinophilic asthma market.