Soliqua 100/33 (insulin glargine; lixisenatide): BLA 208673

Twelve members of the committee recommended approval of the product and two members did not recommend approval based on expected risks associated with introducing a two pen presentation in the healthcare setting.

At the end of the meeting the Advisors were asked if they recommended approval of the fixed combination drug product delivered using the proposed pen devices for the treatment of adult patients with type 2 diabetes.

In fact, I know of no data that suggest more rapid (measured in months) attainment of ADA glucose goal offers a clinical benefit.

In a clinical pharmacology study in adults with type 2 diabetes mellitus, lixisenatide reduced fasting plasma glucose and postprandial blood glucose AUC0-300min compared to placebo (-33.8 mg/dL and -387 mg·h/dL, respectively) following a standardized test meal.

The mean difference (95% CI) in HbA1c reduction between SOLIQUA 100/33 and insulin glargine was -0.5 [-0.6, -0.4] and statistically significant.

At Week 30, SOLIQUA 100/33 provided statistically significant improvement in HbA1c (p value <0.0001) compared to insulin glargine 100 units/mL and lixisenatide-treated patients (-1.6%, -1.3%, and -0.9%).

In fact, some GLP-1 receptor agonists can be injected once weekly, have a similar short term (6 months) glucose lowering effect than Soliqua, are simpler to dose and have less risks of hypoglycemia or weight gain.

Overall the safety analyses revealed that Soliqua carries common risks attributable to both glargine (hypoglycemia) and lixisenatide components (GI-related adverse reaction, allergic adverse reactions, injection site reactions and immunogenicity related risks).

No risks identified require risk management beyond labeling to warrant consideration of a Risk Evaluation and Mitigation Strategy (REMS).

We acknowledge receipt of your submission dated December 21, 2015, of a proposed risk evaluation and mitigation strategy (REMS).

We have determined that, at this time, a REMS is not necessary for Soliqua 100/33 to ensure that its benefits outweigh its risks.

This Prior Approval supplemental new drug application proposes revisions to the prescribing information, Section 6, Adverse Reactions, Hypoglycemia, providing only the severe hypoglycemia events.

Postmarketing requirement pursuant to the Pediatric Research and Equity Act are discussed in the CDTL memorandum and primary review.