(Posted By: Josi Creek)
I
finally have clarity around a befuddling conversation that I had with
an acquaintance with MS who said that her neurologist was going to start
her on the new oral drug that was probably going to be available this
summer.
"What, fingolimod?" I asked.
"No,
I would have remembered that weird name. Something else that starts
with a 'g,' I think," she replied. "He thought it wouldn't be ready so
soon, but now there is news that it might be coming in June. He heard it
at the big neurology meeting from 'sources.'"
Here
is the deal: Gilenya and fingolimod are the same thing, the Novartis
drug FTY720. I guess the name "fingolimod" was just not flying with the
marketing department. In late February, the FDA granted "priority
review" status to Gilenya.
The
FDA grants priority review status to drugs that could have a much
better efficacy or fewer side effects than existing drugs or to drugs
for conditions where no adequate therapy exists. This status reduces the
review period from 10 months to 6 months. However, Gilenya contains a
new active ingredient, so this actually might get extended as the FDA is
likely to require an Advisory Committee meeting to evaluate the risk
management program. However, it looks like real progress is being made
and I estimate that, if all goes according to plan, this drug will be to
market before the end of 2010.
