Takeda’s Maribavir For Post-Transplant Cytomegalovirus Might See Split Panel Vote
First-in-class CMV treatment showed better efficacy in refractory patients with genetic resistance than those without; US FDA advisory committee will separately consider benefit-risk in each type of patient. On the safety side, taste disturbance is the only adverse event that stands out.
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Takeda’s Maribavir Post-Transplant CMV Indication Should Not Be Limited By Resistance, US Panel Says
Advisory committee unanimously endorses novel antiviral for treatment of post-transplant patients with refractory/resistant cytomegalovirus infection, and in the process rejects US FDA’s proposal to distinguish target population based upon genetic resistance.
Keeping Track: J&J’s Targeted Oncologic Rybrevant, Apellis’ C3 Inhibitor Empaveli Approved; New Filings From Takeda, Lilly
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Sarepta’s DMD Gene Therapy Adcomm Likely To Focus On Dystrophin As A Surrogate Endpoint
Cellular, Tissue and Gene Therapies Advisory Committee will weigh whether the increase in dystrophin production seen with SRP-9001 is reasonably likely to predict clinical benefit in Duchenne muscular dystrophy, Sarepta says; agency had previously told the company a panel meeting would not be needed, but it reversed course late in the review.