New Medicines

Faecal incontinence due to external anal sphincter dysfunction


New molecular entity
Innovacell Biotechnologie

Development and Regulatory status

Phase III Clinical Trials
Apr 22Innovacell is aiming for approval of ICEF15 in the EU in 2024, followed by approval in the US in 2026 (preceded by Japan using the conditional approval pathway in 2023) [2].
Dec 13Innovacell and Norgine enter into an exclusive licensing agreement for ICEF 15 in Europe, the Southern Africa District Community (SADAC) and the Middle East and Northern Africa (MENA) region. Under the terms of the agreement, the two companies will co-develop ICEF 15 while Norgine will be responsible for the commercialisation [4].


An autologous cell therapy containing skeletal muscle cells that have been reproduced in vitro
A study using data from The Health Improvement Network, a UK primary care database, reported a rate of first diagnosis per 1,000 person years of 3.1 for men and 3.6 for women aged 60-89 years. For people with dementia, these figures increased by a factor of at least 4 [1].
Faecal incontinence due to external anal sphincter dysfunction

Trial or other data

Jun 22PIII Fedelia trial now also plans to recruit in Bulgaria and Sweden [5].
May 22PIII Fedelia trial to evaluate the clinical safety and efficacy of autologous skeletal muscle derived cells for patients with urge fecal incontinence due to external anal sphincter dysfunction caused by its disruption and/or weakness is due to start (NCT04976153; IC-01-02-5-009). The randomised, controlled, double blind, two armed clinical trial intends to recruit 290 patients in the Spain. Primary outcome is change in frequency of incontinence episodes at 12 months; collection of these data is due to complete May 24 [3,4].