A panel of experts convened by the FDA has come down against approval of Lipocine’s testosterone replacement therapy. The panel voted 13-6 against the risk-benefit profile of Tlando, leaving Lipocine looking down the barrel of a rejection with limited cash to mount a fightback.
Lipocine arrived at the FDA meeting armed with data from two phase 3 trials showing Tlando moves average serum testosterone concentrations up into the normal range in most people. That result was enough for the studies to meet their primary endpoints. But the overall dataset failed to quell fears about cardiovascular adverse events and the drug’s effect on blood pressure.
Those concerns date back to data Lipocine generated to support its first application for approval of Tlando. A 52-week trial run before the 2015 filing tracked a rise in the heart rates of patients who received Tlando and the active comparator topical AndroGel. That trial also reported a decline in HDL cholesterol levels in close to half of participants in the Tlando arm.
Lipocine argued Tlando has a well-characterized safety profile that is comparable to that of AndroGel. But the argument failed to sway the majority of the panel. Even some of the experts who voted in favor of the drug expressed reservations about its widespread use.
“If I were king, I would only allow this drug to be administered by certified subspecialists who took a required course,” the University of Virginia’s Stuart Howards, M.D., said, according to an article in MedPage Today.
The negative vote and likelihood of the FDA rejecting the drug put Lipocine in a sticky situation. Lipocine closed out the last quarter with $26 million in current assets, $9 million of which was in cash or equivalents. Shares in Lipocine fell 50% in premarket trading following the vote, denting its ability to raise money to support a third run at the FDA.
Lipocine’s rejection by the advisory committee was preceded by a negative vote on another low-testosterone drug, Clarus Therapeutics’ Jatenzo. The panel voted 10-to-9 against Jatenzo, which, like Tlando, is in front of the FDA for the second time.