FDA offers AstraZeneca a shortcut on a landmark SGLT2 approval while China greenlights Lokelma
The FDA may have snubbed AstraZeneca in its quest to expand the approval of its SGLT2 diabetes drug to type 1 patients, but regulators are rolling out the red carpet for another big add-on in approvals.
Following some impressive data demonstrating Farxiga’s ability to cut the risk of death or heart failure among patients suffering from reduced ejection fraction (HFrEF), they’ve given the pharma giant a priority review for patients with and without type 2 diabetes. And now it’s on track for a Q2 decision and potential near term rollout in the cardio mega-market.
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