Jaguar Health Pursues Expedited FDA Approval for Rare Paediatric Disease Treatment
Amsterdam, Thursday 7 May 2026
Jaguar Health is advancing FDA talks for crofelemer, a novel therapy already reducing life-sustaining support needs for 4% of children living with an ultrarare, previously untreatable intestinal disorder.
A Critical Regulatory Juncture for MVID
On 6 May 2026, Napo Pharmaceuticals Inc., a subsidiary within the Jaguar Health family, formally announced preliminary discussions with the US Food and Drug Administration (FDA) [1]. The primary focus of these talks is to evaluate the viability of a Breakthrough Therapy Designation (BTD) for oral liquid crofelemer, an investigational treatment targeting Microvillus Inclusion Disease (MVID) [1]. MVID is an ultrarare congenital disorder characterised by a lethal natural history; currently, there are no available therapies, leaving patients entirely dependent on lifelong total parenteral support (PS) for survival [1].
Clinical Milestones and European Expansion
The push for expedited regulatory review is heavily underpinned by promising clinical outcomes.