Orphan Drug Designation For Remdesivir Is 'Consistent' With Precedent, Former FDA Lawyer Says
Attorney who drafted Orphan Drug Act implementing regs says companies need incentive to develop a treatment that may not be available until crisis passes; KEI is mulling citizen petition to request revocation of the designation for Gilead's investigational COVID-19 product.
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Two days after US FDA granted remdesivir orphan status for treatment of COVID-19, Gilead told the agency it is unnecessary. EMA says it would not grant orphan drug designation to a COVID-19 treatment.
Pivot from individual- to multi-patient protocols for expanded access may help generate data to inform regulatory filings and even payer determinations for Gilead’s potential COVID-19 treatment.
Companies are racing to co-develop coronavirus treatments before finalizing deal teams. These team-ups raise questions about what happens after the pandemic subsides.