FDA Advisory Committee Rejects Lexicon's Zynquista for Type 1 Diabetes and CKD
核心洞察
An FDA advisory committee voted against approving Lexicon's Zynquista (sotagliflozin) as an adjunct to insulin for adults with type 1 diabetes (搜索) and chronic kidney disease (搜索) (CKD).
The committee cited concerns that the benefits of Zynquista, a dual SGLT1/2 (搜索) inhibitor, do not outweigh the risks for this patient population.
Lexicon expressed disappointment but noted the committee's discussion suggesting a potential role for Zynquista in specific T1D and CKD subpopulations.
Lexicon Pharmaceuticals faces another setback as an FDA advisory committee voted 11 to 3 against the approval of Zynquista (sotagliflozin) for glycemic control in adults with type 1 diabetes (搜索) (T1D) and chronic kidney disease (搜索) (CKD). This decision casts doubt on the future of the dual SGLT1/2 (搜索) inhibitor as an adjunct to insulin therapy in this patient population, five years after its initial rejection by the FDA.
The primary concern raised by the committee was whether the benefits of Zynquista outweigh its risks. This outcome is less favorable for Lexicon compared to the panel's 2019 vote, which was split 8 to 8 and subsequently led to a complete response letter (CRL) from the FDA. The initial application sought a broader label for all type 1 diabetes (搜索) patients but was hindered by concerns regarding diabetic ketoacidosis (搜索) (DKA).
Previous Attempts and Approvals
Lexicon's appeals against the FDA's decision were unsuccessful. Subsequently, Sanofi, Lexicon's former partner for Zynquista, relinquished the rights to the drug in exchange for a $260 million termination fee. The partnership, established in 2015, was valued at up to $1.7 billion.
Despite failing to secure FDA approval for type 1 diabetes (搜索), Lexicon obtained European approval, though the product was never commercially launched there. However, sotagliflozin received FDA approval under the brand name Inpefa for use in patients at risk of heart failure (搜索).
Potential Subpopulations
Despite the negative vote, Lexicon found some encouragement in the panel's comments suggesting that Zynquista could be beneficial for specific subpopulations of individuals with type 1 diabetes (搜索) and CKD, potentially paving the way for future FDA approval. These subpopulations included patients with a kidney function score between 60 and 90 or those with mild to moderate kidney disease. However, some panellists argued that the number of patients in these categories was insufficient for a well-informed judgment.
Lexicon's Response and Future Plans
"We are disappointed in the outcome of today's advisory committee vote. However, we were encouraged by the rich discussion and outpouring of support across the diabetes community in favour of sotagliflozin being made available to appropriate people," stated Dr. Mike Exton, Lexicon's chief executive.
The FDA is expected to announce its decision on the application by December 20th. Lexicon believes that an FDA-approved treatment, coupled with comprehensive education on risk management, is urgently needed, and their data supports this need.
Recent Licensing Agreement
Earlier this month, Lexicon licensed all ex-US rights to sotagliflozin, encompassing all potential indications, to Viatris for an upfront payment of $25 million, along with royalties on sales. In August, Lexicon announced a strategic shift to concentrate on the commercialization of Inpefa and the potential launch of Zynquista, resulting in a 50% workforce reduction to decrease costs by $40 million.