Win For Axonics As England’s NICE Says Rechargeable Neuromodulation Is Cost-Effective
Health technology assessment body NICE is consulting on draft guidance that recommends Axonics' device for overactive bladder.
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The US FDA approved Axonics’ r-SNM sacral neuromodulation system for treating overactive bladder and urinary retention on 14 November. The agency approved the same device for treating chronic fecal incontinence on 9 September. Axonics expects r-SNM to rival Medtronic's InterStim II non-rechargeable sacral neuromodulation system, but Medtronic claims the r-SNM technology infringes on Medtronic’s intellectual property.
Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.
Around 13,000 people are now expected to be eligible for treatment with the long-acting, injectable Vocabria/Rekambys combination therapy in England.