The FDA has removed a boxed warning concerning the risk of leg and foot amputations for Janssen’s sodium glucose co-transporter (SGLT) inhibitor, Invokana (canagliflozin) – including its combination varieties Invokamet (canagliflozin + metformin) and Invokamet XR (canagliflozin + metformin extended-release). With the removal of the boxed warning, it is expected that Invokana will experience a moderate rebound from a trend of decreasing US sales since 2017, according to GlobalData, a leading data and analytics company.

Jesse Cuaron, Associate Director at GlobalData, commented: “The removal is a reversal of the FDA decision to add a boxed warning label in 2017. Since then, Invokana has experienced decreasing US sales, likely due to a combination of the warning and increased competition from other SGLT inhibitors.”

Key opinion leaders (KOLs) interviewed by GlobalData have communicated that, despite some concerns regarding safety issues around the profile of SGLT inhibitors, they expect the drug class as a whole to experience increased uptake, due to the barrage of clinical trial data that support ongoing label expansions.

Cuaron continues: “In the past few years, clinical trials with Invokana have proven the drug’s potential and have received FDA approval towards reducing the risk of heart attack, stroke, or cardiovascular death in patients with T2D and established cardiovascular disease – in addition to treating diabetic kidney disease (DKD) and reducing the hospitalization risk for heart failure in patients with T2D and DKD.”

The SGLT inhibitor market is becoming increasingly crowded and competitive, with developers continuing to vie for label expansions and best-in-class statuses across multiple disease areas and sub-indications. For Invokana, label expansions have likely helped to decrease the negative sales growth witnessed since 2017.

Cuaron concludes: “Despite the removal, there is the negative connotation/reputation from the boxed warning, which may have lasting effects, in addition to the competitive advantage given to Invokana’s rivals over the past three years. Without a dedicated marketing campaign from Johnson & Johnson to tout Invokana’s updated safety profile, US sales will continue to slip in the foreseeable future.”