Sotagliflozin Hail Mary? Lexicon Seeks Opportunity For Formal Hearing On FDA Intent To Deny Approval
After complete response letter, Lexicon triggers rarely used mechanism for formal hearing, prompting US FDA to publicly list its problems with the proposed type 1 diabetes drug, for which Sanofi had originally sought approval.
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include seven new products, including the COVID-19 vaccines from AstraZeneca/Oxford University and Moderna respectively. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).
Sanofi terminated its alliance for the SGLT1/2 inhibitor Zynquista, giving Lexicon full control of development in type 1 and type 2 diabetes, but it is seeking a new partner ideally with a European footprint.
Following Vyondys 53 rebuff, Sarepta CEO contends it would be "disrespectful" to release the complete response letter, while FDA contends that there is nothing stopping companies from publishing the letters.