Not all medication have a simple path to market, and an FDA rejection can hit onerous. For Lexicon Prescription drugs, the hits maintain coming, within the type of two rejections and a disappointing adcomm for its kind 1 diabetes and persistent kidney illness candidate sotagliflozin.
The FDA first rejected sotagliflozin for kind 1 diabetes sufferers in 2019, when Lexicon was partnered with Sanofi on the drug. The pharma big subsequently ducked out of the partnership through a $260 million fee to Lexicon. Then, the biotech misplaced a bid for an attraction the next yr, however nonetheless the corporate continued to develop sotagliflozin, which was accepted within the EU for as an adjunct remedy to insulin in kind 1 diabetes and launched with the model title Zynquista.
However Lexicon’s ongoing bid to increase into the U.S. kind 1 diabetes market was dealt a 3rd blow final week when an advisory committee voted in opposition to the drug for approval. Whereas the adcomm’s choice is non-binding, the company was in settlement 88% of the time between 2010 and 2021, and the end result highlights an absence of religion within the beleaguered drug. Lexicon CEO Mike Exton discovered a silver lining when committee specialists agreed there was an pressing want for this affected person group, however they in the end determined there was not sufficient knowledge to show the drug’s advantages outweighed the dangers.
“We’re dissatisfied within the consequence of at present’s advisory committee vote,” Exton mentioned in an announcement. “Nevertheless, we have been inspired by the wealthy dialogue and outpouring of help throughout the diabetes neighborhood in favor of sotagliflozin being made out there to acceptable folks with [type 1 diabetes] and [chronic kidney disease].”
Market alternatives
The corporate introduced earlier this yr that it was reducing about half of its “area power” as a part of a $40 million cost-saving effort to organize for the drug’s launch.
It’s a tricky capsule to swallow with a market alternative upwards of $400 million for the affected person group, in keeping with some estimates. Different estimates had projected sotagliflozin might attain $1 billion in gross sales.
Lexicon maintains that sotagliflozin could be the one adjunct remedy to insulin for sufferers with kind 2 diabetes and persistent kidney illness if accepted. The affected person want can be excessive, as solely 20% of kind 1 diabetes sufferers can keep satisfactory glycemic management with simply insulin, Dr. Steve Edelman, professor of medication on the College of California, San Diego, and founder and director of Taking Management Of Your Diabetes, mentioned in Lexicon’s Oct. 31 launch.
Zynquista is an oral SGLT1/SGLT2 inhibitor that already has legs in different indications. However after its EU approval, its advertising authorization was withdrawn in 2022 after Guidehouse Germany, which held the advertising rights, determined to not market the drug.
When the FDA rejected Zynquista in 2019, advisory committee members have been cut up, voting 8-8. This time, with an 11-3 vote, Lexicon’s path to the end line in kind 1 diabetes is even rockier.
The corporate expects the FDA to render a call on Dec. 20.
Coronary heart failure hopes
Lexicon final yr secured an FDA approval in coronary heart failure for sotagliflozin, bought beneath the model title Inpefa for the indication, in addition to for some kind 2 diabetes sufferers with cardiovascular dangers. Inpefa is the corporate’s solely accepted drug on the U.S. market, nevertheless it has but to choose up gross sales traction. Through the second quarter of 2024, Lexicon reported $1.6 million in gross sales and $1.1 million within the first three months of the yr.
There’s seemingly some upside on the best way. Final month, Lexicon penned a $25 million deal with generics big Viatris for the rights to promote Inpefa exterior the U.S. and Europe, with Lexicon retaining some royalty rights. The corporate continues to be removed from reaching projected gross sales of $112 million by 2025 and $576 million by 2028, Reuters reported final yr.
Lexicon’s Inpefa can be going through Massive Pharma competitors. Boehringer Ingelheim and Eli Lilly’s Jardiance can be an SGLT2 inhibitor accepted for lowering cardiovascular danger in kind 2 diabetes sufferers, in addition to coronary heart failure and persistent kidney illness — the identical indications the place Lexicon is seeking to make headway. Jardiance has been a smash success, raking in $8 billion in gross sales in 2023, Boehringer Ingelheim reported. And the drug is so extensively used it landed on the primary 10 medication in Medicare’s newly established drug worth negotiation program, which is able to take impact in 2026.
Past kind 1 diabetes, the corporate is enterprise part 3 testing for a hypertrophic cardiomyopathy indication for sotagliflozin. Elsewhere within the pipeline, Lexicon has a part 2 candidate for diabetic peripheral neuropathic ache and a preclinical weight problems asset.
