Lexicon Pharmaceuticals' sotagliflozin, a dual SGLT1/SGLT2 inhibitor, has encountered another setback in its pursuit of FDA approval for use as an adjunct therapy to insulin in adults with type 1 diabetes and chronic kidney disease. An FDA advisory committee voted against the drug, casting doubt on its potential to expand into the U.S. type 1 diabetes market. This decision follows previous rejections and a withdrawn marketing authorization in the EU.
Advisory Committee's Concerns
The advisory committee's negative vote reflects concerns that the benefits of sotagliflozin may not outweigh the risks for the targeted patient population. While committee experts acknowledged the unmet need for additional therapies in type 1 diabetes, they ultimately determined that the available data did not sufficiently demonstrate a favorable benefit-risk profile. Lexicon CEO Mike Exton expressed disappointment but noted the support from the diabetes community for making sotagliflozin available to appropriate patients.
Market Opportunity and Challenges
Despite the setback, Lexicon aims to tap into a substantial market opportunity, estimated at upwards of $400 million, for type 1 diabetes patients. The company has been preparing for the potential launch of sotagliflozin, including cost-saving measures such as reducing its field force. However, the path forward is uncertain, as the FDA's decision, expected on December 20, will likely align with the advisory committee's recommendation, given the agency's historical agreement rate of 88% with advisory committees between 2010 and 2021.
Sotagliflozin's Existing Approvals and Competition
Sotagliflozin is currently approved in the U.S. under the brand name Inpefa for heart failure and certain type 2 diabetes patients with cardiovascular risks. However, Inpefa's sales have been modest, with $1.6 million reported in the second quarter of 2024. Lexicon is also facing competition from established therapies like Boehringer Ingelheim and Eli Lilly's Jardiance, an SGLT2 inhibitor approved for similar indications and generating substantial revenue, with $8 billion in sales in 2023.
Strategic Repositioning and Future Prospects
To navigate these challenges, Lexicon is focusing on strategic repositioning and partnerships. A recent $25 million deal with Viatris grants Viatris the rights to sell Inpefa outside the U.S. and Europe, while Lexicon retains royalty rights. Additionally, Lexicon is exploring other potential indications for sotagliflozin, including hypertrophic cardiomyopathy, with ongoing phase 3 testing. The company also has a phase 2 candidate for diabetic peripheral neuropathic pain and a preclinical obesity asset in its pipeline.
