Abbvie Inc (ABBV)

[Just the facts maam]

Question for the board, is AbbVie interested in being the leader in male and female testosterone restoration and advancing the benefits beyond hypogonadism?

I see that AbbVie was the primary sponsor for the clinal trial titled A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (TRAVERSE) which was estimated to have 6,000 participants and a study time frame to completion of approx. 60 months. However, when first posted they had an estimated completion of 48 month completion Start date May 2018 and completion June 2022. Additionally the stopped recruiting at with 5,246 participants.

It appears they were more concerned to meeting their original completion date of June 2022, than getting 6,000 participants.

Then I see that after 9 years of dormancy, the clinical trial titled Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women (BLOOM), involving 3,656 postmenopausal women at an elevated risk of cardiovascular events, was updated on October 27, 2021 by submitted a Certification/Extension request to delay submission of results. As it currently stands there us no obligation to submit results as the primary completion date was well before January 18, 2017 when the Final Rule for submitting results applied. It is more likely an NDA has been file or in the works, where a Certification request would be required. Arguably AbbVie would be best positioned to submit the NDA, as the Study Director, Dr Michael Snabes is now a Senior Medical Director , AbbVie Global Clinical Research and Development. In this trial he discover that restoring Testosterone reduced the risk of cardiovascular events by at least 70% over expected outcomes and by an undisclosed percentage over placebo. Additionally, by December 2015, it was discovered that it reduced breast cancer events over expected events and over placebo. None of this information has been made public other than in patent application and subsequent.

If AbbVie were intent on advancing the benefits of testosterone restoration, there is a 700,000 participant trial titled Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes due to be completed in November 2022, which could drive interest in the potential benefit of testosterone restoration.

Wondering if it is another tool in countering LOE for Humira.

Good luck to all.