AstraZeneca gains EU nod for diabetes triple; Amgen and Duke launch real-world PCSK9 observational study
→ Weeks after winning EU approval to start marketing dapagliflozin as Forxiga, AstraZeneca has racked up another OK for a triplet combo involving the SGLT2 diabetes drug. Named Qtrilmet, the pill combines Forxiga with the DPP-4 inhibitor Onglyza (saxagliptin) and the bedrock drug metformin in a modified-release format. That 3-in-1 approach proved superior in reducing average blood glucose levels to a number of other dual combinations across 5 Phase III trials, including Forxiga plus metformin, Onglyza with metformin, or glimepiride with metformin.
The EU label specifically covers patients whose type 2 diabetes is not adequately controlled by existing therapies, as well as those who are already taking the three drugs separately. FDA regulators waved the combo — Qternmet in the US — through in May.
→ Amgen and Duke University are co-launching a real-world observational study to measure the effect of PCSK9 inhibitors on long-term lipid management and cardiovascular health. Amgen and Duke say this is the first study of its kind. For 5 years, they will follow a prospective registry of 8,500 patients eligible for a PCSK9 inhibitor alongside an electronic health record-based registry of adults hospitalized with atherosclerotic cardiovascular disease.
→ GSK said it will have limited supplies of its shingles vaccine, Shingrix, until 2024, when the company is scheduled to open a new bioreactor. The pharma company’s planned gradual launch into the US was blown open when regulators cleared the vaccine not only for people reaching 50 but also to replace an existing product. It’s estimated to prevent shingles in about 90% of recipients.