AstraZeneca’s Farxiga (dapagliflozin) is expected to significantly strengthen its presence in the the sodium-glucose co-transporter-2 inhibitor (SGLT-2I) class of the cardiovascular and metabolic arena after recent findings suggested the drug can both reduce cardiovascular (CV) risk and decrease the risk of new-onset diabetes in HF-REF patients. Key opinion leaders (KOLs) interviewed by GlobalData have expressed the need for drugs that can address the comorbidities of T2D, and, in addition, prevent those with existing conditions such as CVD from developing T2D. If AstraZeneca is able to achieve a label update from the FDA for reducing the risk of T2D onset in HF-REF patients, this would increase its market share in the T2D, valued at ~$60bn in 2019, and the CVD market.

Akash Patel, Healthcare Analyst at GlobalData, commented: “In the DAPA-HF trial, Farxiga demonstrated a 32% relative risk reduction, which was defined as statistically significant for the prespecified endpoint of new-onset T2D. The significance of this sub-analysis, in conjunction with the wider DAPA-HF trial, is that dapagliflozin has been able to demonstrate reduction in both incidence of T2D and mortality within a single trial. In addition, Farxiga is the first SGLT-2I to demonstrate efficacy for diabetes prevention.”

A current challenge for the SGLT-2I market is that the safety profile may deter physicians from prescribing the drug to older patients, who constitute about 20% of the T2D population, due to side effects such as the increased risk of lower limb amputation, urinary tract infections (UTIs), and decreased kidney function. Approval for the treatment of additional comorbidities or related disorders that lead to T2D is key to attaining rapid uptake, and therefore providing differentiation within the SGLT-2I drug class.

Patel concludes: “Competition has been heating up recently in the SGLT-2I space – as seen through the increasing numbers of competitors such as Eli Lilly and Boehringer Ingelheim achieving an update for Jardiance to reduce risk of CV death in patients with T2D in the EU and US; and from Johnson & Johnson’s Invokana (canagliflozin) to treat diabetic kidney disease (DKD) and to reduce the risk of hospitalization for HF in patients with T2D and DKD in the US, and reduce the risk of CV events in the EU. Overall, GlobalData predicts that AstraZeneca will continue to take strategic steps towards differentiating Forxiga from its SGLT-2I competitors.”

Want to find out more? Send your questions to Rebecca Panks, PR Executive at GlobalData (pr@globaldata.com)