AstraZeneca gets FDA green light for diabetes adjunct treatment
AstraZeneca’s extended-release, once-daily tablets Qternmet XR (dapagliflozin, saxagliptin and metformin hydrochloride) was developed to improve glycaemic control in adults with type 2 diabetes (T2D).
The US Food and Drug Administration (FDA) approval is based on two Phase III trials, which evaluated combinations of dapagliflozin and saxagliptin alongside metformin over 24 weeks, in patients with inadequately-controlled T2D.
“Type 2 diabetes is a complex disease”, a spokesperson from AstraZeneca told us and added that Qternmet XR “may benefit patients in the US who require improved glycaemic control by adding an SGLT-2 inhibitor and DPP-4 inhibitor to metformin in a convenient once-daily tablet”.
In one trial, treatment with 5mg dapagliflozin/5mg saxagliptin, in addition to metformin, demonstrated statistically-significant decreases in HbA1c (average blood glucose levels), and an increase in the number of patients achieving the recommended HbA1c treatment goal of <7%.
In the second trial, treatment with extended-release 10mg dapagliflozin/5mg saxagliptin, in addition to metformin, demonstrated statistically significant decreases in HbA1c, and an increase in the number of patients achieving an HbA1c <7%.
Cardiovascular, renal and metabolism therapy areas are, as stated, a “key growth driver” for the company, and AstraZeneca is “investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities”.
A timeframe for a US market launch for Qternmet XR could not be announced; however, a spokesperson from AstraZeneca told us that the company will “evaluate current market dynamics and access coverage to determine the appropriate time for a successful launch.”
Recently, the company announced plans to build a new manufacturing facility for oral solid dosage drugs in Durham, UK, in collaboration with GSK and CPI.