Another testosterone therapy is getting the heave ho at the FDA.
Lipocine $LPCN reported this morning that the agency has issued a complete response letter rejecting Tlando as a new therapy for hypogonadism. The biotech spelled out what the FDA says is lacking in the application, and plans to follow up with a sit-down to define a path back to a new pitch.
Shares of the biotech tumbled 15%.
The FDA has significantly raised the bar on testosterone replacement treatments, unhappy with the way they’ve been widely used by a graying generation of men — despite some health risks.
Lipocine was hammered back in January when an expert panel turned thumbs down on their application, looking to profit on a therapy that was designed to replace the gels now in use. That vote came a day after Clarus was stiff armed on its second try on Jatenzo. And a whole lineup of companies have been stymied on this front in recent years.
“I voted ‘no’ because … the indication is the same as the existing preparations and we know there is huge off-label use,” noted committee member Douglas Bauer of the University of California San Francisco, in a report from MedPage Today. “I think that’s unacceptable, and I don’t think that the sponsor’s proposals to try to change that, frankly, are likely to be very successful.”
Lipocine, nevertheless, will soldier on. The company identified a variety of areas they would need to work on, including offering more insights into the therapy’s effect on blood pressure and tracking patients to determine when they should stop using the drug.
“While we are disappointed by the FDA’s decision, the deficiencies identified in the CRL are within our expectations following the meeting we had on January 10, 2018 with the Bone, Reproductive and Urologic Drugs Advisory Committee of the FDA. We are assessing the content of the CRL, including the information that may be needed to resolve the deficiencies. We remain committed to work with the FDA to bring Tlando to patients,” said CEO Mahesh Patel.
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