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US FDA Approves Sanofi SA (ADR) (SNY) Soliqua 100/33, Novo Nordisk A/S (ADR) (NVO) Xultophy 100/3.6

The US Food and Drug Administration (FDA) has recently approved the Soliqua 100/33 (insulin glargine and lixisenatide injection) of Sanofi SA (ADR) (NYSE:SNY) and the Xultophy 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection) of Novo Nordisk A/S (ADR) (NYSE:NVO) for the treatment of inadequately-controlled type 2 diabetes among adult patients.

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Soliqua 100/33

Soliqua 100/33 is the resulting once-daily injection of the combination of Lantus (insulin glargine 100 units/mL) and lixisenatide, a GLP-1 receptor agonist.

The US FDA approved Soliqua 100/33 after Sanofi SA (ADR) (NYSE:SNY) had completed a Phase 3 clinical trial and submitted the results to the former. The insulin intensification clinical trial, which enrolled nearly 2,000 subjects, has demonstrated that Soliqua 100/33 can lower average blood sugar over time (HbA1c) better than Lantus.

“Sanofi continues to be a pioneer in developing diabetes therapies and in bringing forward new treatment options for the approximately 50 percent of patients whose blood sugar levels remain uncontrolled on daily basal insulin,” emphasized Elias Zerhouni, M.D., Sanofi President of Global Research and Development (R&D), boasting about how Sanofi 100/33 is yet another extension of the company’s treatment options for adult patients with inadequately controlled type 2 diabetes.

Soliqua 100/33 will start rolling out in the US by January.

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Xultophy 100/3.6

On the other hand, Xultophy 100/3.6 is the resulting once-daily injection of the combination of Tresiba (insulin degludec injection) and Victoza (liraglutide). Primarily, it is intended to enhance glycemic control among adult type 2 diabetes patients.

The results of the Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes (DUAL) clinical development program have backed the decision of the US FDA on Xultophy 100/3.6. Three clinical trials had been conducted, enrolling nearly 1,400 subjects overall.

The approval of Xultophy 100/3.6, along with that of Soliqua 100/33, creates a new portfolio classification of commercially available treatment options for diabetes patients.

Xultophy 100/3.6 will begin rolling out in the first-half of 2017 as well.

On Tuesday, Sanofi SA (ADR) (NYSE:SNY) closed at $39.86 while Novo Nordisk A/S (ADR) (NYSE:NVO) closed at $31.78.

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Note: This article is written by Adam Russell and was originally published at Market Exclusive.

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