We now have a powerful game changer for
people whose lives have been marred by
unrelenting side effects.
wearing down, angry at my disease and angry with
myself for putting my family through this.”
She soldiered on and completed the trial as promised but then couldn’t bring herself to continue on
either of the two drugs. “I had to have a break,”
she said. Although many people stop their MS
med with no obvious effect, Losasso had an attack
just a few weeks later.
An oral option
Unlike others who have dropped treatment—and
gone without protection from mostly silent MS
damage—Losasso was offered an out. She was
eligible for a clinical trial of an MS medication in
a capsule. The trial was designed to explore the
best dosages, so all the volunteers were given active
medication. The weekend bouts of aches and fever
were gone, and with them her depression, anxiety
and fear. And her MS was controlled. The experi-
mental drug was fingolimod, approved last Sep-
tember under the brand name, Gilenya.
“Having the option of an oral drug has truly made
a difference in my outlook on life,” she told the
FDA advisory committee.
The MS drug pipeline
An oral MS disease modifier has been urgently
sought ever since the first injectables were
approved in the early 1990s. We listed 14 oral
drugs “in the pipeline” in the Summer 2009 issue
of Momentum. Some have since been ejected as
ineffective, a few others are stalled at this writing,
one has emerged into the marketplace and several
seem headed for an FDA review sometime this
ing previous chicken pox or varicella virus
exposure with a possible recommendation of
varicella vaccine before starting treatment
•;Pregnancy:;A;“wash-out”;period;of;at;least;two
months recommended for women before try-
ing to conceive
Information on the drugs listed on the next
pages is drawn from reports on clinical trial
protocols and early results. It is all subject to
change.
When a drug receives formal marketing
approval, the FDA decides exactly what the
drug label, patient information and prescribing information materials will say about dosages, side effects, prescreening, and any risk
control measures.
