(Adds FDA and company comment, background)
WASHINGTON Oct 10 U.S. health regulators have
approved Lev Pharmaceuticals Inc's LEVP.OB experimental drug
to treat a rare genetic disease that causes swelling of the
hands, feet and other parts of the body.
The drug, called Cinryze, aims to treat hereditary
angioedema, a spontaneous and potentially deadly disorder that
can be triggered by stress, surgery or infection, the U.S. Food
and Drug Administration said in a statement on Friday.
ViroPharma Inc VPHM.O has agreed to buy Lev in a $443
million deal expected to be completed by the end of the year.
Hereditary angioedema disease also can cause swelling of
the airway and larynx, which can make it impossible for those
experiencing it to breathe and cause asphyxiation, the FDA
Up to 10,000 people in the United States have the
condition, according to the agency.
Lev's intravenous drug, a protein made from human plasma,
is given every three or four days to help prevent swelling, it
"Cinryze should greatly enhance treatment options for those
with hereditary angioedema and potentially save lives," Dr.
Jesse Goodman, head of the FDA's Center for Biologics
Evaluation and Research, said.
The drug should be available for patients later this year,
Lev said in a statement.
Company studies show Cinryze reduces the frequency of
attacks or prevents them in most patients, the company said.
Common side effects include rash near the injection site and
The drugmaker is working to ensure that health insurers
cover the product, it added.
Before the FDA announcement, shares of Lev rose more than 8
percent to close at $2.38 while shares of ViroPharma closed up
0.8 percent at $9.57.
(Reporting by Susan Heavey; Editing by Tim Dobbyn and Carol