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FDA Accepts Lexicon's (LXRX) NDA for Type I Diabetes Drug
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Shares of Lexicon Pharmaceuticals (LXRX - Free Report) rose more than 5% on Tuesday after the company announced that the FDA accepted its resubmitted new drug application (NDA) seeking approval for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).
A final decision is expected by Dec 20, 2024. If approved, the product will be marketed under the brand name Zynquista with a commercial launch expected in early next year.
Lexicon had initially submitted an NDA in 2018 for sotagliflozin in T1D indication. However, the FDA issued a complete response letter (CRL) to the NDA in 2019 after one of its advisory committees issued a split opinion regarding its approval. Management stated that the agency considers the resubmission as a complete response to this CRL.
Shares of Lexicon Pharmaceuticals have surged 45.8% year to date compared with the industry’s 2.6% decline.
Image Source: Zacks Investment Research
We remind investors that sotagliflozin was approved by the FDA last year to reduce the risk of death and hospitalization in adults with either heart failure or those with type II diabetes mellitus (T2D), CKD and other cardiovascular risk factors. The drug is being marketed under the name Inpefa.
An oral SGLT inhibitor, the commercial launch of Inpefa continues to progress across the country, driven by demand across the cardiology community and improving payer access.
Per Lexicon, Inpefa is one of the three FDA-approved SGLT inhibitors to treat heart failure. The other two SGLT inhibitors are marketed by pharma giants AstraZeneca (AZN - Free Report) and Eli Lilly (LLY - Free Report) . AstraZeneca markets Farxiga (dapagliflozin), while Lilly markets Jardiance (empagliflozin). LXRX is likely to face stiff competition from both these companies.
Both AstraZeneca’s Farxiga and Lilly’s Jardiance are blockbuster drugs and directly compete with each other in multiple indications, including T2D and heart failure. During first-quarter 2024, AstraZeneca generated $1.89 billion from Farxiga sales, a 45% rise from the year-ago period’s levels. Lilly added $686.5 million from Jardiance sales, up 19% year over yearfrom the year-ago period’s levels.
Image: Bigstock
FDA Accepts Lexicon's (LXRX) NDA for Type I Diabetes Drug
Shares of Lexicon Pharmaceuticals (LXRX - Free Report) rose more than 5% on Tuesday after the company announced that the FDA accepted its resubmitted new drug application (NDA) seeking approval for sotagliflozin as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD).
A final decision is expected by Dec 20, 2024. If approved, the product will be marketed under the brand name Zynquista with a commercial launch expected in early next year.
Lexicon had initially submitted an NDA in 2018 for sotagliflozin in T1D indication. However, the FDA issued a complete response letter (CRL) to the NDA in 2019 after one of its advisory committees issued a split opinion regarding its approval. Management stated that the agency considers the resubmission as a complete response to this CRL.
Shares of Lexicon Pharmaceuticals have surged 45.8% year to date compared with the industry’s 2.6% decline.
Image Source: Zacks Investment Research
We remind investors that sotagliflozin was approved by the FDA last year to reduce the risk of death and hospitalization in adults with either heart failure or those with type II diabetes mellitus (T2D), CKD and other cardiovascular risk factors. The drug is being marketed under the name Inpefa.
An oral SGLT inhibitor, the commercial launch of Inpefa continues to progress across the country, driven by demand across the cardiology community and improving payer access.
Per Lexicon, Inpefa is one of the three FDA-approved SGLT inhibitors to treat heart failure. The other two SGLT inhibitors are marketed by pharma giants AstraZeneca (AZN - Free Report) and Eli Lilly (LLY - Free Report) . AstraZeneca markets Farxiga (dapagliflozin), while Lilly markets Jardiance (empagliflozin). LXRX is likely to face stiff competition from both these companies.
Both AstraZeneca’s Farxiga and Lilly’s Jardiance are blockbuster drugs and directly compete with each other in multiple indications, including T2D and heart failure. During first-quarter 2024, AstraZeneca generated $1.89 billion from Farxiga sales, a 45% rise from the year-ago period’s levels. Lilly added $686.5 million from Jardiance sales, up 19% year over yearfrom the year-ago period’s levels.
Zacks Rank
Lexicon currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.