Gilead's Request To Revoke Remdesivir Orphan Designation Reflects Pandemic Pressures
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.
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Office of New Drugs Director Peter Stein said in an interview that a large amount of coronavirus-related work is arriving at the FDA, but so far staff are keeping up.
Public health advocates say that commercial concerns must take a back seat to health interests if COVID-19 technologies are to be made available to those who need them. But industry says that relaxing IP protections is not the solution and that many companies have already invested significant amounts of money in potential new treatments and vaccines.
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.