Sanofi seeks FDA & EMA approval for type 1 diabetes treatment

27th March 2018 (Last Updated August 7th, 2019 14:53)

Sanofi has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA), and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), for its type 1 diabetes drug sotagliflozin.

Sanofi seeks FDA & EMA approval for type 1 diabetes treatment
Sanofi has submitted a New Drug Application to the FDA, and a Marketing Authorisation Application to the EMA, for its type 1 diabetes drug sotagliflozin.

Sanofi has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA), and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), for its type 1 diabetes drug sotagliflozin.

Sotagliflozin is an investigational dual inhibitor of sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). These proteins are responsible for glucose regulation, the former causing glucose absorption in the gastrointestinal tract and the latter facilitating glucose reabsorption by the kidney.

Sotagliflozin is used in combination with insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus.

The drug was discovered by Texas-based biopharma company Lexicon Pharmaceuticals, which in November 2015 signed a licence agreement granting Sanofi exclusive rights to develop, manufacture and commercialise sotagliflozin.

“The NDA and MAA submissions for sotagliflozin represent important milestones for Lexicon and for people in the United States and Europe who are living with the challenges of type 1 diabetes,” Lexicon chief medical officer Pablo Lapuerta said.

“These filings highlight our strong investment in internally-discovered therapies and are a culmination of the largest Phase 3 programme for an oral anti-diabetic agent ever conducted in type 1 diabetes, in the broadest range of patients, resulting in the most comprehensive efficacy and safety database. I am extremely proud of our team members who have worked tirelessly to achieve this step towards bringing this important potential therapy to patients with type 1 diabetes.”

“With approximately three-quarters of adult patients in the US with type 1 diabetes not reaching their A1C goals, sotagliflozin would represent an important advance in managing these patients,” USC Clinical Diabetes Programs director Dr Anne Peters said. “It potentially will be the first oral agent in the US to be used in combination with insulin to improve glycaemic control and patient outcomes.”

Through its agreement with Sanofi, Lexicon retained the exclusive option to co-promote the medicine’s commercialisation for the treatment of type 1 diabetes. Sanofi is responsible for all clinical development and commercialisation of sotagliflozin for the treatment of type 2 diabetes worldwide, excluding Japan, and is solely responsible for the commercialisation of sotagliflozin for the treatment of type 1 diabetes outside the US, excluding Japan.