Human Genome Sciences FDA Panel Live Blog (Lupus drug)

The Street ^ | 2010-11-16 | Adam Feuerstein

[kevkrom]

Go to http://www.thestreet.com/story/10921534/1/human-genome-fda-panel-live-blog.html to view the live blog of the event.

[kevkrom]

Today is the meeting of the FDA panel for the review of Benlysta, a monoclonal antibody that promises to be the first novel treatment for Lupus in over 50 years. The antibody was developed by Human Genome sciences (HGSI) in partnership with Glaxo Smith-Klein (GSK) and met its primary Phase III endpoints developed under a special protocol assessment (SPA) with the FDA.

Trading of HGSI stock has been halted pending the panel meeting's conclusion.

(Disclaimer: I am long HGSI.)

[kevkrom]

Update: Human Genome presentation complete, addressed key concerns in FDA briefing without negative comment from panel. Currently on break, FDA will present next.

[kevkrom]

Update: Lunch break. FDA, as expected, focused on concerns. In my opinion, their use of pooled data from the multiple sub-studies fore safety concerns opens the door for HGS/GSK to point out that several of the secondary endpoints were statistically significant if the data is allowed to be pooled.

It’s the FDA’s job to consider risk, but benefits should also be viewed in the same light, as I see it.

[kevkrom]

Lunch break is over, time to resume. Public comments scheduled for the next 90 minutes. Expect to hear from several lupus sufferers in attendance.

[kevkrom]

19 folks so far in public comment, the vast majority lupus sufferers or parents of lupus sufferers — all in favor of approval.

[kevkrom]

Panel members discussing now. One (Blumenthal) is clearly a “no” vote, arguing that Belysta doesn’t show efficacy, which is completely at odds with the FDA and independent analysts’ views.

[rusty millet]

Good luck. FDA has been acting pretty capriciously lately. - Amylin, Arena, Mela.

[kevkrom]

In this case, however, the study design was approved with the FDA beforehand with an SPA. There's literally no reason to not approve barring methodological errors.

From the live blog:

[Comment From Avik Roy Avik Roy : ]
That was a statistically ignorant discussion by Blumenthal

[kevkrom]

Panel votes:

Efficacy - 10 to 5 in favor
Safety - 14 to 1 in favor
Recommend to Market (key vote) - 13 to 2 in favor

While the FDA gets the final word, this almost certainly means that Benlysta will be the first novel treatment for lupus in over 50 years.