Proveca gets positive ema opinion for its first children's medicine drug (sialanar)

Proveca Limited today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of an EU-wide Paediatric Use Marketing Authorization (PUMA) for Sialanar® (glycopyrronium, oral solution), for the Symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders.   

The CHMP is responsible for issuing the EMA's scientific evaluation and opinions on all Marketing Authorization Applications (MAAs) for medicines for human use. Their positive opinion on Sialanar® forms the scientific basis for the European Commission to issue a binding decision for the PUMA, a centralized marketing authorization which is valid throughout all the Member States of the European Union (EU) as well as in the European Economic Area (EEA), namely Norway, Iceland and Liechtenstein. The anticipated timeframe for the European Commission decision is by the fourth quarter of 2016.  A summary of the CHMP opinion is available here. Please select "S" to access the Sialanar® summary opinion.  

Children living with motor or neurological disorders, such as cerebral palsy, are often unable to effectively swallow the saliva they produce resulting in unavoidable chronic drooling, with significant adverse consequences for the child’s wellbeing and quality of life. Sialanar, will be the first medicine licensed in Europe to treat chronic drooling.

Dr Helen Shaw, Co-founder and Director of Proveca Limited, said: “Incessant drooling associated with neurological disorders such as cerebral palsy can be an incredibly difficult issue to manage. Unfortunately, it is a symptom that comes with a number of health and hygiene implications, and can make a huge impact on a young person’s confidence and self-esteem. As well as causing irritation and infection around the mouth, it can have profound effects on the digestive system, causes dehydration and the constant wetness can often produce a foul odour. ” 

Co-founder and director Dr Simon Bryson added: “Sialanar has the capability of making a huge improvement to the quality of life of many young people. Now that we have reached this significant milestone with EMA, we are looking forward to launching this much needed product across Europe to help in the treatment of children and young people with this disabling condition”

Proveca is a leading pharmaceutical company in the development and licensing of medicines specifically designed for children and adolescents and is currently developing innovative, child-friendly medicines in the fields of cardiology, neurology, epilepsy and pain management.