SIALANAR (glycopyrronium bromide) - severe sialorrhoea

The Committee deems that the clinical benefit of SIALANAR (glycopyrronium bromide) 320 µg/mL oral solution is substantial in the MA indication.

Considering:

• demonstration of the superiority of glycopyrronium bromide compared to placebo:
  • on the change in total DIS score from baseline to day 84 of treatment compared to baseline (primary endpoint), with a mean change of -25.5 points versus -8.8 points (p<0.001),
  • on all the ranked secondary endpoints, particularly in terms of responder rate and impact on drooling at days 84 and 28 of treatment,
• robust efficacy data versus placebo limited to a duration of 12 weeks, in a chronic disease context, and non-comparative long-term follow-up data suggesting a sustainability of the therapeutic effect for up to 252 days of treatment,
• the insufficiently covered medical need in an off-label context for medicinal products not authorised in paediatric patients,
• the absence of data relative to the possibility of retreatment;
• the lack of evidence of an improvement in quality of life, in the absence of robust data,
• the safety profile of glycopyrronium bromide in children and adolescents marked by the known typical anticholinergic adverse effects,

the Committee deems that SIALANAR (glycopyrronium bromide) 320 µg/mL oral solution provides a minor clinical added value (CAV IV) in the current care pathway for the symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.