* Drug aims to prevent blood clots for those on chemotherapy
* FDA advisers say not clear which patients drug targets
By Anna Yukhananov
SILVER SPRING, Md., June 20 French drugmaker
Sanofi SA failed to win a U.S. advisory panel's
support for an injection meant to prevent blood clots in certain
cancer patients, making it unlikely the drug will be approved in
the United States.
The panel of outside experts to the Food and Drug
Administration voted 14 to 1, with one abstention, on Wednesday
to recommend against approval of the semuloparin injection for
cancer patients getting chemotherapy who are particularly at
risk for blood clots.
The FDA usually follows panel recommendations, although it
is not required to, and will make a final decision later.
Most panel members said the company had not done a good job
of defining exactly which patients would benefit most from the
drug, especially as those taking the medicine were also at
higher risk of bleeding.
"Cancer patients have a lot to deal with just in treating
their cancer with chemotherapy," said panel member Dr. Mikkael
Sekeres, from the Cleveland Clinic Taussig Cancer Institute.
"When we add ... medicines to prevent complications, we have
to be particularly careful in not adding harm," said Sekeres.
Sanofi has said cancer patients getting chemotherapy have a
6-1/2 times higher risk of getting blood clots than patients
without cancer, and no other medicines are currently approved
specifically to prevent the clots in patients on chemotherapy.
But FDA staff said approving an anti-clotting drug
specifically designed for those on chemotherapy would change the
practice of medicine, since groups that set cancer treatment
guidelines only recommend such medicines in very specific
They also doubted the clinical value of semuloparin, since
only a small number of people who took the drug in clinical
trials actually had issues with clotting, and most people died
from other problems.
During the clinical trial, only 3.4 percent of people who
took a placebo had a blood clot. At the same time, about 5
percent of patients died from other causes, raising doubts about
the importance of preventing blood clots in cancer patients.
Semuloparin was also tied to a higher risk of bleeding
compared with a placebo, with about one-fifth of patients having
some bleeding issues while taking the drug, including bleeding
into a critical area or organ.
Sanofi said it was disappointed with the panel's vote, given
the lack of treatment options for cancer patients who want to
prevent blood clots, known clinically as venous thromboembolism
"Often clinically silent, VTE is a potentially
life-threatening complication of cancer and its treatment that
may increase morbidity, mortality and medical care and cost,"
the company said in a statement.
Sanofi's shares closed down 0.7 percent at 57.37 euros on
the Paris stock exchange, compared with a 0.3 percent rise on
the CAC 40 Index.