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 United Therapeutics received a rare pediatric disease priority
review voucher in March after its drug, Unituxin, was approved by
the U.S. Food and Drug Administration to treat neuroblastoma, the
company said on Wednesday.
The voucher, which offers a plethora of incentives, makes its holder
eligible to have one of its drugs reviewed in six months, compared
to the standard 10 months.
AbbVie did not disclose its plans for the voucher.
The company has multiple drugs in late-stage development, as well as
therapies for which marketing applications have been submitted,
including treatments for cancer, multiple sclerosis and diabetic
nephropathy.
BioMarin Pharmaceutical Inc was the first to receive a rare
pediatric disease priority review voucher in February 2014 following
the approval of its drug, Vimizim, to treat a rare congenital enzyme
disorder.
The company sold the voucher five months later to Regeneron
Pharmaceuticals and France's Sanofi SA for $67.5 million, allowing
the companies to reduce the lead Amgen Inc had in the race to bring
a new class of cholesterol-lowering drugs to the market.
The French drugmaker earlier this year bought another pediatric
voucher from Retrophin Inc for $245 million, after the latter
received approval for its drug, Cholbam.
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The pediatric disease priority review program takes off from a
similar program intended to help spur the development of new drugs
for neglected diseases.
(Reporting by Natalie Grover in Bengaluru; Editing by Sriraj
Kalluvila)
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