EU approves Zynquista for adults with type 1 diabetes
There was good news for French pharma major Sanofi (Euronext: SAN) on Friday, with the European Commission granting marketing authorization for Zynquista(sotagliflozin), developed under a cooperation with US firm Lexicon Pharmaceuticals (Nasdaq: LXRX), at once-daily doses of 200mg and 400mg, for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes (T1D) mellitus and a body mass index >=27kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy.
Just last month, The US Food and Drug Administration issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista, but the companies gave no indication as to what additional data was required, with that news sending Lexicon’s shares plunging as much as 40%.
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