March 8, 2006
MS drug Tysabri should return to market: panel
By Lisa Richwine
GAITHERSBURG, Maryland (Reuters) - Biogen Idec's multiple
sclerosis drug Tysabri can return to the market as long as
there are safeguards to closely monitor patients for a
life-threatening side effect, a U.S. advisory panel unanimously
said on Wednesday.
suspended Tysabri sales in February 2005 after three patients
developed a rare brain and spinal cord infection and two of
Members of the U.S. Food and Drug Administration advisory
panel voted 12-0 that Tysabri sales could resume if Biogen
creates a mandatory patient registry to track side effects and
imposes other controls.
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 the 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 had appealed to the panel on Tuesday
to let them decide for themselves whether Tysabri's risks were
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.
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.
Biogen has promised a series of restrictions on Tysabri's
use aimed at making sure patients are fully informed of risks
and that any signs of PML are promptly recognized and reported
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)