PARIS (dpa-AFX) - Sanofi announced that the U.S. Food and Drug Administration approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.
The company noted that Soliqua 100/33 will be delivered in a single pre-filled pen for once-daily dosing covering 15 to 60 Units of insulin glargine 100 Units/mL and 5 to 20 mcg of lixisenatide using SoloStar technology, the most frequently used disposable insulin injection pen platform in the world. Soliqua 100/33 will be available in U.S. retail pharmacies in January 2017.
SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, that may improve blood sugar (glucose) control in adults with type 2 diabetes, when used with diet and exercise in people who are not controlled with long-acting (basal) insulin (less than 60 units daily) or lixisenatide.
Under the terms of the license agreement between Sanofi and Zealand, which covers lixisenatide and any combination product that includes lixisenatide, Sanofi is responsible for all development and commercialization including the financing.
The approval of Soliqua by the U.S. FDA triggers a milestone payment of $25 million to Zealand from Sanofi. Zealand is eligible to receive remaining milestone payments of up to $110 million as well as royalties on global sales. Royalties correspond to tiered, low double-digit percentages of Sanofi's global sales of AdlyxinTM/Lyxumia plus a fixed low double-digit percentage of global net sales of Soliqua/Suliqua.
Soliqua 100/33 is the combination of Lantus (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection, studied in a Phase 3 program of more than 1,900 patients.
In an insulin intensification study, Soliqua 100/33 showed better HbA1c (average blood sugar over time) lowering versus Lantus with a majority of the 736 patients (55% vs. 30%) achieving the American Diabetes Association target of less than 7% at 30 weeks. Patients treated with Soliqua 100/33 experienced similar rates of documented (less than or equal to 70 mg/dL) hypoglycemia compared to Lantus-treated patients.
The most frequently reported adverse events included hypoglycemia, as well as nausea (10%), nasopharyngitis (7%), diarrhea (7%) and upper respiratory tract infection (5%).
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