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slcimmuno Member Level Tuesday, 06/20/17 08:36:33 PM
Re: None
Post # of 186790

Otezla data - FDA

Pulled the Apremilast approval docs for closer look at what the bar is for Prurisol

In the 2 pivotal Otezla trials (pg 17-19)
https://www.accessdata.fda.gov/drugsatfda_doc...0StatR.pdf

PRIMARY EFFICACY

1. PASI 75
- 33.1% Otezla vs 5.3% placebo
- 28.8% Otezla vs 5.8% placebo

MAJOR SECONDARY EFFICACY

2. sPGA (0 or 1 w/at least 2-pt drop from baseline)
- 21.7% Otezla vs 3.7% placebo
- 20.4% Otezla vs 4.4% placebo

OTHER EFFICACY

1. PASI 50
- Otezla 58.7% vs 17% placebo
- Otezla 55.5% vs 19.7% placebo

2. Achieved PASI 75 and sPGA 2-pt drop
- 20.3% Otezla vs 3.5% placebo
- 18.6% Otezla vs 4.4% placebo

Other factors: Otezla took 16 weeks to get to these numbers and only around 8% achieved PASI 90

Prurisol Phase 2b switches from IGA to PASI 75 as primary so we'll have a direct comparison on the Primary -- also have as Secondary Outcome the sPGA 2-pt drop.

https://clinicaltrials.gov/ct2/show/NCT02949388

Getting ancy -- getting closer to Showtime, first look to see if Prurisol in the P2b is faster on the uptake and as good as (or maybe better than) Otezla -- daresay even eating into the biologics turf ... of course worst case, it fails (say it ain't so)

Tick tock, t-minus a couple months

The full FDA data archive on Apremilast / Otezla
https://www.accessdata.fda.gov/drugsatfda_doc...000TOC.cfm

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