Parking Soldier’s comments Xanelim, Amevive and 507
*Xanelim*
I don't pay too much attention to Xoma filing times: they're ridiculous--let's see, the company (and Genentech) just have to convince the FDA that all of these issues are no problem:
a) no audiometry done in Trial 2059 (the second Phase III) when concerns were raised in trial 2058 (the first Phase III)
b) higher incidence of HSV reactivation in treated groups
c) 2 hospitalizations with ERYTHRODERMA (BAD PSORIASIS!!!!) related to the drug and/or to its withdrawal
d) suspicious malignancy rate--Genentech hemmed and hawed for long periods at the end of the conference call: "we won't review the case-by-case records"
e) 16% flare rate, which should be adjusted higher because of a misleading demoninator
f) ER visits for acute side effects
g) ambiguity about dose-response between the trials
h) possible increase in cardiovascular events
Does anyone really believe that the FDA could reject the asthma drug Xolair without any real safety problems, but let Xanelim coast by with all of the above concerns? I don't think so!!!!
So, approval timelines are more important than filing timelines:
*Amevive*: hard to say, but I think it will be approved on first go-round: on market, Q4 2002
Xanelim: on market (if they're lucky) with black-box label or other warnings(malignancy risk, infection risk, hearing loss) in q1 2004 after filing in q4 2002 (or after the second filing--first will be rejected by FDA, if attempted)
*MEDI-507: on market in late q1 2004*
I don't think the NDA for 507 will be that late--the first Phase III will start in q1 of 2002 and I suspect that a second will start in Q3, after the final Phase II is done--
I suspect that the first Phase III will be 12 weeks with a subsequent "off" period for 12 weeks and then a re-treatment period--thus, the total time will be 36 weeks; that data could be fully collected by year-end 2002--
A second Phase III would likely start in Q3 2002, but only need to have 12-week data to allow for filing--MEDI could make the trial longer, but probably won't have to as disease rebound and flares will not likely occur (similar to Amevive)
Thus, all key Phase III data could be ready by year-end 2002 enabling a q1 03 filing and a q1'04 launch--
Things for MEDI to fool around with in their last Phase II to guide the second Phase III would be: higher doses, alternate dosing intervals (every-other-week is already being examined--half-life is longer than all of the competitors), high doses for 4 weeks with dose tapering to non-T-cell depressing levels (what i expect to see in Phase III as well) and a regimen employing low initial doses followed by a "step-up" in therapy
Most of this is speculation, obviously but I've been following psoriasis trials for almost 3 years....
For what it's worth..... |
