Dec 23 The U.S. Food and Drug Administration
said on Monday it has approved Novo Nordisk's drug
Tretten to prevent bleeding in patients with a rare blood
Patients with congenital Factor XIIIA-subunit deficiency do
not make enough of the Factor XIII protein that is important for
normal blood clotting, the FDA said. Factor XIII is composed of
subunits A and B and Factor XIII deficiency is usually caused by
a deficiency of the A subunit.
Tretten was studied in 77 patients with the disorder and was
effective in preventing bleeding in 90 percent of the patients
when given monthly, the FDA said. Side effects included
headache, pain in the extremities and at the injection site.
Congenital Factor XIII affects an estimated one in 3 million
people globally and is associated with life-threatening
bleeding, impaired wound healing and miscarriage.
The drug is expected to generate sales of $84 million by
2018, according to the average estimate of three analysts polled
by Thomson Reuters.
Novo Nordisk acquired the rights to Tretten from
ZymoGenetics Inc in 2004. Novo agreed to pay a royalty
on sales, although details of the royalty payment were not
disclosed. ZymoGenetics was acquired by Bristol Myers Squibb
Co in 2010.
The product was approved last year in Europe and Canada. It
is sold in Europe under the brand name NovoThirteen and contains
the active substance catridecacog, which is structurally the
same as the human Factor XIII A subunit. It is produced by
genetically engineered yeast cells.