While the rest of Merck's pipeline has been refocused and driven forward, sugammadex remains mired in regulatory woes at the FDA.
What's wrong with sugammadex? Plenty, evidently. Earlier this year the FDA capped 7 years of discussions and setbacks with its third straight rejection.
Regulators have never been satisfied with the hypersensitivity study that was done for the application, requiring more site inspections. And that forced the FDA to cancel another advisory committee review and spurn the latest application.
Merck ($MRK) has consistently maintained that this program is one of their crown jewels in the pipeline, even gaining R&D chief Roger Perlmutter's endorsement after he joined the pharma giant. But the drug has instead tended to highlight the old Merck's unending R&D woes prior to Perlmutter's arrival.
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