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PTJA04 Final Project Plan – Sotagliflozin for adult patients with Type 1 Diabetes Mellitus who have inadequate blood glucose control using insulin or insulin analogues

Please see the below Final Project Plan of the Fourth Pharma Joint Assessment on ‘sotagliflozin for adult patients with Type 1 Diabetes Mellitus who have inadequate blood glucose control using insulin or insulin analogues.’

Timelines will change slightly due to the suggested label change by CHMP to approve ‘sotagliflozin for patients with Type 1 Diabetes Mellitus and with a body mass index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.’

Once timelines are finalised, an updated Project Plan will be published accordingly.

The Project Plan is available here.