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Keeping Track: New Claims For Tukysa, Brukinsa; US FDA Wants More Patients To Support Donanemab, Pediatric Airsupra Bids

Executive Summary

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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The BTK inhibitor demonstrated superiority to AbbVie/J&J’s Imbruvica for overall response in relapsed/refractory CLL, in addition to hitting a progression-free survival endpoint versus chemotherapy in the first-line.

US FDA Rejects Lilly’s Bid For Donanemab Accelerated Approval In Early Alzheimer’s

More long-term data for donanemab needed, FDA says. Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.

Airsupra Could Help Revive AstraZeneca's Respiratory Fortunes

The US Food and Drug Administration has approved AstraZeneca and Avillion’s respiratory drug Airsupra, making it the only rescue medication cleared for as-needed use to reduce risk of asthma exacerbations.

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