Concerns grow on safety issues tied to Neurocrine Biosciences rare disease drug
Two months after an open letter flagged potential safety issues, patient advocates and some experts are sounding the alarm on Vykat XR. The drug, sold by Neurocrine Biosciences, treats Prader-Willi syndrome. This condition can cause an insatiable feeling of hunger. Since approval 18 months ago, the therapy has been linked to seven deaths. Nearly 100 others were hospitalized. STAT obtained the case reports from regulators via the Freedom of Information Act. The reports do not prove causality. Many cases involved complex medical issues and multiple medications. Yet some experts argue the evidence is sufficient to conclude Vykat is causing unacceptable harm.
Two months after an open letter flagged potential safety issues, patient advocates and some experts are sounding the alarm on Vykat XR. The drug, sold by Neurocrine Biosciences, treats Prader-Willi syndrome. This condition can cause an insatiable feeling of hunger. Since approval 18 months ago, the therapy has been linked to seven deaths. Nearly 100 others were hospitalized. STAT obtained the case reports from regulators via the Freedom of Information Act. The reports do not prove causality. Many cases involved complex medical issues and multiple medications. Yet some experts argue the evidence is sufficient to conclude Vykat is causing unacceptable harm.