First-In-Class Dapaglifozin Headed For FDA Advisory Committee Review
This article was originally published in The Pink Sheet Daily
Executive Summary
In highly safety-conscious climate for diabetes drugs, safety of SGLT-2 inhibitor dapagliflozin is bound to face intense scrutiny.
You may also be interested in...
Avandia REMS Requires Doctors To Tell Patients About Actos’ CV Safety
The Risk Evaluation and Mitigation Strategy for GlaxoSmithKline’s Avandia (rosiglitazone) includes a prominent role for Takeda’s competing thiazolidinedione Actos (pioglitazone).
Actos' Bladder Cancer Signal May Hinge On Dose, Duration Of Use
A five-year interim analysis of a 10-year epidemiological study showed no significant overall increased risk between exposure to Takeda's pioglitazone and bladder cancer, although an increased risk was seen among patients with the highest cumulative dose and the longest duration of exposure.
Dapagliflozin Performance In Phase III Leaves Concerns, Particularly About Urinary Infections
Efficacy for Bristol-Myers Squibb/AstraZeneca's SGLT-2 inhibitor is arguably lackluster, but drug could still find attractive role as an add-on therapy.