Testosterone drugs under FDA review
From an ad for AbbVie's AndroGel
The FDA is giving testosterone therapy a second look. The regulator announced Friday that two studies have prompted it to review the impact of these drugs to see whether the treatments were associated with an increased risk of stroke, heart attack and death. The regulator was already monitoring the situation, but said in a statement that this latest move is meant to “reassess this safety issue.”
The assessment could affect drugs such as AbbVie's market leader AndroGel and Lilly's Axiron.
The studies of note include a Veterans Affairs study of men who had low serum testosterone, an average age of 60 and underlying cardiovascular disease. The study indicated testosterone upped the risk of heart issues and death by around 30%.
A second study of older and younger men with pre-existing heart disease found the risk of heart attack doubled among this patient group for men who were at least 65 years old and on testosterone therapy.
While sales of AbbVie's AndroGel declined almost 21% in the fourth quarter, to $289 million, and slid just over 10% to slightly over $1 billion for the year, it is still a presence on the balance sheet. Lilly's Axiron first hit pharmacies in 2011. The company did not tease out the drug's financial performance in last week's fourth-quarter or annual tallies, but Bloomberg noted in November that expectations were for Axiron prescriptions to bring in around $168 million in year-end sales for the Indianapolis, IN, drugmaker.