EMA CHMP restricts and redefines ipidacrine indications
- CHMP revised authorised uses of ipidacrine, restricting them to acquired mono‑ and polyneuropathies, symptomatic Alzheimer’s disease, intestinal atony, adjunctive use in some stroke/traumatic brain injury recoveries, and myasthenia gravis.
- Use for neuritis, polyneuritis, polyradiculoneuropathy, myasthenic syndrome and demyelinating diseases has been removed.
- Safety guidance: increased side‑effect risk at doses >80 mg/day and a possible risk of liver toxicity; caution in patients with current or past abnormal liver function.
- CHMP recommends ipidacrine be prescribed only by physicians experienced in diagnosing and treating the indicated conditions and notes dosing recommendations have been revised in the product information.
CHMP conclusion
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) finalised a review of ipidacrine‑containing medicines and recommended narrowing and better defining their authorised uses to align with available data and current standards of care. The opinion will be forwarded to the European Commission for a legally binding decision.
Revised indications
Ipidacrine may now be used for symptomatic treatment of acquired mononeuropathies and polyneuropathies, symptomatic treatment of mild to moderately severe Alzheimer’s disease (with or without vascular dementia), symptomatic intestinal atony, adjunctive symptomatic treatment of motor or bulbar impairment during recovery after ischaemic or haemorrhagic stroke or traumatic brain injury, and adjunctive symptomatic treatment of myasthenia gravis.
Uses removed and rationale
The CHMP removed uses for neuritis, polyneuritis, polyradiculoneuropathy, myasthenic syndrome of various aetiologies and demyelinating diseases because the supporting studies were small, methodologically limited or no longer aligned with current standards of care.
Safety, prescribing and next steps
No new safety signals were identified, but there is increased risk of side effects at high doses and a possible risk of liver toxicity, so caution is advised above 80 mg/day and in patients with abnormal liver function. The committee advises prescriptions only by clinicians experienced in these conditions and notes dosing recommendations have been revised; the full updated product information lists the detailed changes. The review was initiated under Article 31 at the request of the Irish authorities.
Source: EMA