Safety concerns rise as Neurocrine's Prader-Willi drug linked to deaths and hospitalizations
Patient advocates and several experts are voicing increasing alarm over the safety profile of Neurocrine Biosciences' therapy for Prader-Willi syndrome.
The drug, Vykat XR, received approval 18 months ago and has since been associated with seven reported deaths and nearly one hundred hospitalizations.
A former FDA regulator has called for the drug's withdrawal, while other clinicians are urging caution pending further review. Case reports detailing the adverse events were submitted to regulators and obtained by STAT.
The mounting safety data could prompt regulatory scrutiny and affect Neurocrine's standing with investors and healthcare providers.
This writeup was produced by pharmadog from original reporting by STAT.
Original headline: “STAT+: Concerns grow on safety issues tied to Neurocrine Biosciences rare disease drug”
read at STAT ↗
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