FDA to Lexicon: Yeah, that's still gonna be a no from us
Lexicon’s last hopes for a quick resurrection of its Type 1 diabetes drug in the US have been quashed.
The Texas-based biotech announced that the FDA’s Office of New Drugs has declined its appeal of the complete response letter from the agency rejecting their SGLT1/2 drug. The second rejection is the latest bump in a long, rough slide for a company whose drug sotagliflozin once garnered $300 million upfront and $1.4 billion in potential milestones to be Sanofi’s new prospective diabetes blockbuster.
Lexicon execs immediately switched focus to an appeal it now plans to make to CDER, but shares $LXRX continued their long-running fall, dropping 14% to $3.03 on Monday. Shares went for over $13 as recently as June of 2018.
Lexicon and Sanofi showed up late to the game, after J&J, AstraZeneca, and Eli Lilly and Boehringer Ingelheim had collectively rolled out 3 SGLT inhibitors. But those drugs were approved for only Type 2 diabetes and targeted either SGLT 1 or SGLT 2. Lexicon promised to hit both of the glucose-regulating proteins and get the drug approved for Type 1 diabetes. Beginning in September 2016, they announced successful trial result after successful trial result.
But when it came time for regulatory review, the FDA’s outside experts hesitated. A council of 16 split down the middle, 8-8, on whether to approve the drug. The problem was sotagliflozin appeared to raise the risk of diabetic ketoacidosis (DKA), a potentially life-threatening condition that arises when the body runs out of insulin and starts to break down fat too quickly. Breaking down the fat, the liver creates ketones that turn the blood acidic.
“While all patients with type 1 diabetes may to some degree be at risk for DKA, sotagliflozin therapy clearly increases that risk, and the risk may be unpredictable,” regulatory staff wrote.
The reviewers largely agreed that even if the drug was approved, the DKA risk would make it only acceptable for a select group of particularly attentive T1 patients. Shares tumbled 25%
The FDA rejected the drug in March. Shares tumbled another 24%.
Multiple Phase III failures in Type 2 diabetes followed. Sanofi had seen enough. They exited the deal, and shares tumbled 70%.
In September, the pharma giant paid $260 million to officially close the door on the partnership deal. Lexicon’s stock actually perked up: 21%.
This isn’t it, though, either for Lexicon or the drug sotagliflozin. The EMA approved the drug for Type 1 diabetes patients and despite mixed-at-best results from Phase III trials, the company is plowing ahead in Type 2. They said in their Q3 call they’re aiming for regulatory submissions on both continents in the first half of 2020.
As for Sanofi? It’s not just diabetes; every business is under review.