Replies to post #217396 on Biotech Values

[DewDiligence]

ABBV/NBIX—...I wonder if they are trying to...position [Elagolix] for long term management of fibroids if they can thread the needle and get adequate efficacy without affecting BMD long-term?

That's exactly the plan. Please see slides #55 and #60 from ABBV's R&D Day presentation in Oct 2017 (http://phx.corporate-ir.net/External.File?t=1&item=VHlwZT0yfFBhcmVudElEPTUyNjQzMTR8Q2hpbGRJRD02ODI3MzA= ).

[oc631]

The first is that birth control pills (often given continuously without a withdrawal bleed) is the most commonly employed first line treatment for bleeding, even bleeding associated with fibroids. So there was no positive control

This raises an interesting question: Does the FDA provide guidance on whether a sponsor should use a control group (that may be the existing SOC) but that is not FDA approved for the indication being studied?

[DewDiligence]

ABBV/NBIX—FDA approves Orilissa (elagolix) for endometriosis pain:

https://finance.yahoo.com/news/abbvie-receives-u-fda-approval-123000190.html

The US list price is ~$10K/yr. (The recommended course of treatment is two years.)

Orlissa also works for management of uterine fibroids, having hit all endpoints in two phase-3 trials (#msg-138708805), but it is not yet approved in that indication.