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I reviewed the transcript of the FDA panel's meeting during which Paxene was approved for further FDA consideration:
fda.gov
I made the following observations:
a) Ivax reps were woefully unprepared;
b) you and I are not the only ones who do not know how Paxene is different from paclitaxel or taxol. The panel did not know either and Ivax reps were not forthcoming;
c) IMHO, the FDA will likely ask for more information.
Jackson
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Below are some highlights i found interesting and my comments:
[sic: Is this true about BN not surviving without Paxene?]
PAXENE PATIENT:
We urge you to immediately approve
Paxene for the treatment of KS. A small company like
Baker-Norton cannot survive another couple of years,
therefore they will have to discontinue operations and
I will no longer have the drug. Ultimately, the
promise of my future will be taken away again. Thank
you
[sic: comparing taxol and paxene]
DR. HARRIMAN [of Ivx]: We feel that, first of all
the two products, Taxol and Paxene, although they both
contain the same active moiety, are different
proprietary preparations with different formulations.
Although we cannot address that specifically, it is at
least a possibility that some differences in side
effect profiles may be related to differences in
formulation.
[sic: Ivax unprepared]
DR. SCHILSKY [panel member]: I'm not asking you to
relate it to any clinical parameter, I just want to
know if you have data on, you know, number of days or
number of hours with a concentration above the
threshold value.
DR. DUCHIN [IVX]: Oh, we have that, but we
don't have it today.
[sic: Ivax unprepared]
DR. SWAIN [panel member]: And the second question. Can
you discuss the hepatotoxicity with and without the
protease inhibitors that you saw?
DR. HARRIMAN [IVX]: Yes. [Pause.] We don't
have that data summarized, but we can certainly get
that for you. But unfortunately, we don't have it
available today.
[sic: Who knows what Paxene is?]
DR. SCHILSKY [panel member]: Ken, I had just two
questions. You mentioned right at the beginning that
the formulation which is proposed for marketing is
different from the formulation which was actually
studied as under the Phase II study. Could you
comment on that any further with respect to the FDA's
level of comfort that the proposed formulation is
actually equivalent to the formulation for which we
have seen data.
DR. KOBAYASHI [IVX]: I think that involves some
proprietary considerations. I think perhaps the
company would be, or our chemist would be, perhaps,
better suited to answer that question. Or perhaps one
of my superiors.
DR. SCHILSKY: I just think it's going to
be a little bit difficult for us to make a judgement
about these data --
DR. KOBAYASHI: I understand.
DR. SCHILSKY: -- if what we have been
spending the morning listening to is not even the drug
that's being proposed for marketing.
DR. KOBAYASHI: I understand.
[sic: who knows what Paxene is?]
DR. OZOLS [panel member]: Well here I think you have to
address -- I mean, that's pretty broad. Three months
ago we approved another drug. So how does that relate
to Taxol? What about a patient who has received Taxol
already for this indication, for basically the same
indication that has progressed or stopped responding?
Are we saying that they should also be candidates for
Paxene?
CHAIRMAN DUTCHER: Dr. Johnson says no.
Okay.
DR. JOHNSON [IVX]: I think we thought that was
obvious.
DR. OZOLS: Well, I mean are they the same
drug, are they different drugs? Are you going to say
they are different formula drugs and there is
different proprietary drugs, they may have different
responses, toxicities? All that's been alluded to.
Are you saying that this is identical to
Taxol?
DR. JOHNSON: We are not saying. That's
yet to be determined.
DR. TEMPLE [panel member]: That's not fundamentally
different from what you make of the situation whenever
there are two manufacturers who make the same active
moidient to two different drug products. Usually your
thought is if you failed on one thing, you wouldn't
try the generic.
DR. OZOLS: Right.
[sic:final vote]
CHAIRMAN DUTCHER: Okay. Is Paxene
approvable for the indication of use after failure of
first-line or subsequent systemic therapy for
treatment of advanced AIDS-related Kaposi's sarcoma?
All those who vote yes? One, two, three, four, five,
six, seven, eight, nine, ten, eleven. The vote is
eleven yes.
Any other comments?
[No response.]
CHAIRMAN DUTCHER: Thank you very much.
The meeting is adjourned. |
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