This article is part of an ongoing blog series profiling the 12 new, game-changing drugs predicted to achieve blockbuster status by 2022 in the 2018 edition of Drugs to Watch, the annual industry forecast and analysis from Clarivate Analytics. Read the full Drugs to Watch report here or follow the series for the latest updates.
The 2018 Drugs to Watch report, the annual industry forecast and analysis from Clarivate Analytics, predicted the market entry of Pfizer and Merck’s potential blockbuster Steglatro (ertugliflozin), a sodium glucose co-transporter-2 (SGLT-2) inhibitor, for the treatment of type 2 diabetes. Steglatro, and its fixed-dose combinations with Januvia (sitagliptin, as Steglujan) and metformin (as Segluromet), are now available in the U.S. and also received EU approval in March 2018 around the time of the release of the Drugs to Watch report.1,2,3
Diabetes is a chronic, progressive disease affecting approximately 30 million in the U.S. of whom 90% to 95% have type 2 diabetes. Early stage diabetes is managed with oral antidiabetics, including generic metformin/glitazone or branded dipeptidyl peptidase-4 (DPP-4) inhibitors and SGLT-2 inhibitors. SGLT-2 inhibitors are the newest oral treatment option and promote excretion of glucose into the urine by inhibiting renal absorption of glucose.4,5,6
Steglatro is a late entrant to an increasingly crowded SGLT-2 inhibitor market.”
Steglatro is a late entrant to an increasingly crowded SGLT-2 inhibitor market, competing with first-to-market Invokana (canagliflozin; Johnson & Johnson; launched in 2013), Farxiga (dapagliflozin; AstraZeneca; launched in early 2014) and Jardiance (empagliflozin; Boehringer Ingelheim/Eli Lilly; launched in late 2014).7 However, Steglatro does have specific strengths that should help it gain market share, particularly significant HbA1C reductions in combination with Merck’s DPP-4 market leader Januvia in the first-line setting as shown in the VERTIS SITA trial (HbA1C reductions of up to 1.7 versus 0.4 percentage points for the combination and placebo, respectively) and combined with Januvia versus Januvia alone in patients inadequately controlled with metformin in the VERTIS Factorial trial (HbA1C reductions of 1.5 versus 1.1 percentage points, respectively).8,9 Steglatro is also efficacious as a monotherapy (in the VERTIS Mono trial) and in combination with metformin (in the VERTIS MET trial), and showed significant weight loss and blood pressure-lowering effects in all studies.10,11,12
SGLT-2 inhibitors are one of the fastest-growing classes of diabetes drugs given their convenient oral route of administration, strong HbA1c efficacy data, reduction in body weight and antihypertensive effect. Steglatro’s rival Jardiance became the first diabetes therapy to show cardiovascular benefits in the paradigm-shifting EMPA-REG OUTCOME trial and won FDA approval to cut the risk of cardiovascular complications in December 2016.13 Cardiovascular data for competitor Invokana from the CANVAS program were filed in October 2017 and outcomes data from the DECLARE study of Farxiga are expected in late 2018.14,15 Positive cardiovascular data are key to helping Steglatro consolidate a place among the other SLGT-2 inhibitors and a cardiovascular outcomes study (VERTIS CV) is ongoing with results expected in 2019.16
Real-world evidence indicates that SGLT-2 inhibitors could significantly decrease heart failure hospitalizations and deaths, supporting use earlier in treatment and thereby adding more potential patients.”
Real-world evidence indicates that SGLT-2 inhibitors could significantly decrease heart failure hospitalizations and deaths, supporting use earlier in treatment and thereby adding more potential patients.17 While market-leading Invokana was the only SGLT-2 inhibitor t with blockbuster sales in 2016, Farxiga had achieved blockbuster status by 2017 (Farxiga 2017 sales: $1.074 billion; Invokana 2017 sales: $1.141 billion), and a rapid rise in sales of this drug class is predicted, with Steglatro a significant contributor. At the time of writing the 2018 Drugs to Watch report in mid-March, Cortellis Consensus Forecast data (source Thomson Reuters I/B/E/S) predicted Farxiga to lead the market by 2022 ($2.025 billion), followed by Jardiance ($1.713 billion), and another novel class member Zynquista (sotagliflozin; a dual SGLT-1 and SGLT-2 inhibitor from Lexicon/Sanofi; $1.193 billion), then Steglatro ($1.087 billion) and Invokana ($652 million; the decline a possible result of amputations observed in the CANVAS trial). Approximately three months later, the ranking remains unchanged but 2022 forecasts for all drugs have increased: Farxiga ($2.354 billion), Jardiance ($1.651 billion), Zynquista ($1.329 billion; now filed for type 1 diabetes with phase III development for type 2 diabetes ongoing18,19), Steglatro ($1.275 billion) and Invokana ($1.139 billion).