Will Abbott Laboratories lose what was to have been a big money maker? The answer should be known on Thursday, when an FDA advisory committee meets to decide the fate of Trilipix, a so-called fenofibrate pill that was approved in 2008 for lowering cholesterol but, more recently, was linked to a higher rate of heart problems among women who combined the drug with a statin.

However, the clinical significance of the finding, which was disclosed in a study known as ACCORD, is not entirely certain, which is why the FDA panel is meeting. However, one question to be addressed is whether the FDA should withdraw approval for using the med in conjunction with a statin or, instead, revise the labeling and possibly include study results. Another option is to require another study (see this).

The ACCORD study found that combining a similar and older Abbott drug called TriCor with a statin failed to reduce heart attacks and other cardiac problems (read here), but an analysis of a so-called gender subgroup suggested the possibility of heart problems increased for women in the trial (you can read more in the FDA briefing materials here).

The possibility that the FDA would yank the indication for using the Abbott drug with a statin has been anticipated ever since the ACCORD results became known. Consequently, Wall Street lowered expectations. Earlier this year, for instance, Wells Fargo Securities analyst Larry Biegelsen forecast US sales would decline 3 percent this year to $1.3 billion and drop to $990 million in 2012, especially as generic TriCor pills become next year. Last year, combined sales were $1.5 billion.

UPDATE: In an investor note today, Biegelsen offers an update: “We are lowering our 2013-2015 TriLipix/Tricor franchise sales to $244 million, $219 million and $197 million, respectively, from $447 million, $402 million and $382 million, respectively, to better reflect anticipated generic Tricor erosion of the entire franchise. TriCor/Trilipix total prescriptions are currently declining 10 percent to 15 percent year over year in the US. It is our understanding that Abbott has pulled back promotion of TriCor/TriLipix.”

He also points out that Cleveland Clinic cardiologist Steve Nissen, who he says has been a “vocal critic” of fibrates, will not be on the panel this time, which he views “as a positive.”

Trilipix, which is also approved as a monotherapy, and TriCor are designed to lower triglycerides and raise HDL. But the government-funded ACCORD study examined whether adding a fenofibrate with a statin could reduce heart problems in diabetics. Patients were given Abbott’s TriCor and Merck’s Zocor, or the statin plus a placebo. Abbott maintains the findings support current labeling for Trilipix, because the combo helped patients with high triglycerides and low HDL.

questionmark thx to purpleslog on flickr