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7.2. Protocols of PASS non-imposed in the marketing authorisation(s) 32
See Annex 16.2
7.3. Results of PASS imposed in the marketing authorisation(s) 33
None
7.4. Results of PASS non-imposed in the marketing authorisation(s) 34
See Annex 16.4
7.5. Interim results of imposed and non-imposed PASS and results of nonimposed
PASS submitted before the entry into force of the revised
variations regulation 35
7.5.1. Rufinamide – INOVELON (CAP)
Evaluation of interim PASS results
Regulatory details:
PRAC Rapporteur: Isabelle Robine (FR)
Administrative details:
Procedure number(s): EMEA/H/C/000660/MEA 011.9
Procedure scope: Submission of the fifth annual interim report for Inovelon registry study
MAH(s): Eisai Ltd
Background
Inovelon (rufinamide) is a centrally authorised antiepileptic medicine, indicated as adjunctive therapy
in the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 4 years and
older. A post marketing registry (European LGS Registry) study to collect further safety data on long
term exposure to rufinamide and more specifically data on status epilepticus, hypersensitivity,
common adverse events identified with antiepileptic drugs and the potential for developmental and
maturation impairment in children and adolescents is ongoing and the MAH presented an interim
analysis report that was assessed by the Rapporteur. Together with the interim report the MAH notified
their intent to terminate the European LGS Registry.
Summary of recommendation(s) and conclusions
The PRAC commented that the adverse events (AEs) reported in the rufinamide group were consistent
with the known safety profile of rufinamide and that long-term data on the safety profile in rufinamidetreated
patients or other AEs were accumulated in the LGS registry over 6 years.
The PRAC noted the recruitment challenges of the registry despite the previous extension of the
recruitment time and the introduction of some additional measures. It was accepted that further
extension of the recruitment time is unlikely to achieve the expected study size.
32 In accordance with Article 107m of Directive 2001/83/EC, supervised by PRAC in accordance with Article 61a (6)
of Regulation (EC) No 726/2004
33 In accordance with Article 107p-q of Directive 2001/83/EC
34 In accordance with Article 61a (6) of Regulation (EC) No 726/2004, in line with the revised variations regulation
for any submission as of 4 August 2013
35 In line with the revised variations regulation for any submission before 4 August 2013
Pharmacovigilance Risk Assessment Committee (PRAC)
EMA/PRAC/438418/2014 Page 39/75