March 8, 2006
MS drug Tysabri should return to market: US panel
By Lisa Richwine
GAITHERSBURG, Maryland (Reuters) - A panel of independent
experts on Wednesday unanimously urged the U.S. return of
Biogen Idec's multiple sclerosis drug Tysabri, a medicine
abruptly pulled from the market last year after it was linked
to a life-threatening side effect.
If the Food and Drug Administration followed the
recommendation, it would signal a reversal of fortune for
Biogen and partner Elan Corp. of Ireland, and a victory for MS
patients who have pleaded for access to the medicine.
The advisory panel said Tysabri must have mandatory
controls to ensure that patients are aware of risks and that
any new cases of a possibly fatal brain infection are found
quickly. All 12 members voted in favor of resuming Tysabri
Only one prescription drug, GlaxoSmithKline Plc's irritable
bowel treatment Lotronex, has returned to the U.S. market after
being withdrawn over safety concerns.
Biogen and Elan voluntarily suspended Tysabri sales in
February 2005 after three patients developed the infection
known as progressive multifocal leukoencephalopathy, or PML.
Two of them died.
Many patients do not find relief with current MS drugs and
should have Tysabri as an option, panel members said.
"Most people in (Tysabri) studies did not have a relapse
and did not have disability progression," said Dr. Karl
Kieburtz, the panel chairman. Patients in those studies
received monthly infusions of Tysabri for two years.
The panel also voted 7-5 that Tysabri could be considered
as an initial treatment for some MS patients, without requiring
them to try another therapy first.
The FDA will make the final decision but usually follows
advisory panel recommendations. A ruling is expected by the end
of the month.
Dozens of MS patients, some in tears, appealed to the panel
on Tuesday to let them decide for themselves whether Tysabri's
risks were worth taking. They said Tysabri produced dramatic
improvements in motor function and should be available as long
as patients are told of the risks.
Multiple sclerosis causes progressive disability that can
include blurred vision, weakness, poor muscle coordination and
loss of memory and mental function as nerves lose their
insulating sheath. About 300,000 Americans have MS.
Tysabri is a key drug for Cambridge, Massachusetts-based
Biogen and Irish drugmaker Elan. It had been dubbed a
billion-dollar-a-year seller before the safety concern arose.
"It's quite a ringing endorsement to get a recommendation
to have it back on the market with a unanimous vote," Nomura
Code Securities analyst Mike Ward said.
Sanford Bernstein analyst Geoff Porges predicted Tysabri
sales of $700 million a year by 2010.
"There's going to be a real cautionary statement toward
patients and physicians, and they're going to think twice about
putting patients on the drug. Initially, there are going to be
a lot of desperate patients who jump on it, but it's probably
going to be a slow build.
"This is not going to become a routine drug in the next
year or two," he said.
Biogen has promised restrictions on Tysabri's use aimed at
making sure patients know of risks and promptly recognize and
report any signs of PML to the company and regulators. In
addition to creating a patient registry, the company said it
would limit distribution to approved infusion centers.
Older MS drugs cut the number of relapses by one-third,
while Tysabri reduced those episodes by two-thirds. Some panel
members cautioned, however, that many patients fare well on the
Dr. Ralph Sacco, a panel member and neurologist from
Columbia University in New York, said he was concerned that
Tysabri was "perceived as a wonder drug" and may be overused.
The FDA first approved Tysabri, known generically as
natalizumab, in November 2004. About 7,000 patients took the
drug before sales stopped.
Trading in Biogen and Elan shares was halted during the
(Additional reporting by Bill Berkrot in New York)