Dapagliflozin’s Commercial Appeal Could Dim With Bladder Cancer Concerns
Executive Summary
Lingering questions surrounding an imbalance in bladder cancer cases – and how FDA decides to handle the issue in labeling – could threaten the diabetes drug’s uptake, particularly given the absence of a similar signal for J&J’s competing SGLT-2 inhibitor Invokana, already on the market.
You may also be interested in...
AZ’s Dapagliflozin Closes On Canagliflozin With India’s SEC Nod
A new frontier in diabetes care is set to open in India with the Special Expert Committee giving a green light to AstraZeneca’s dapagliflozin, after holding back on safety concerns for a prolonged period.
AstraZeneca’s Farxiga Label Includes, But Downplays, Bladder Cancer Risk
AstraZeneca’s SGLT-2 inhibitor Farxiga (dapagliflozin) finally clears FDA, and without a black box warning on bladder cancer risk – allowing the drug to compete with J&J’s first-to-market Invokana.
Post-approval Studies Aim To Resolve Lingering Safety Fears For Diabetes Drug Farxiga
Agency finally clears AstraZeneca/Bristol Myers-Squibb’s SGLT-2 inhibitor Farxiga (dapagliflozin), but with post-marketing strings attached.