UK: Cytyc's Novasure awaits NICE (National Institute for Clinical Excellence) verdict
This article was originally published in Clinica
Cytyc has launched its Novasure radiofrequency endometrial ablation system in the UK, as part of plans to expand its EU market coverage of the technology. The impedance-controlled bipolar ablation system used to treat menorrhagia (heavy menstrual bleeding) was CE-marked in 2002, but Novasure's real success in the UK is set to hinge on the current assessment of the technology by the National Institute for Clinical Excellence (NICE).
You may also be interested in...
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.
Sarepta’s Vyondys: Renal Toxicity Concerns That Delayed Approval Get Enhanced Postmarketing Scrutiny, Label Warning
Sarepta must perform enhanced pharmacovigilance for serious renal toxicity events and rhabdomyolysis with the Duchenne muscular dystrophy drug, which carries a label warning for renal toxicity. Approval letter includes 2024 target completion date for ESSENCE confirmatory trial.
Efficacy data were striking to committee members, but they want to ensure postmarketing plans gather adequate data to address safety questions.