Velaglucerase Alpha Prescribing Survey
Research type
Research Study
Full title
EVALUATION OF THE EFFECTIVENESS OF RISK MINIMISATION MEASURES: A SURVEY AMONG HEALTH CARE PROFESSIONALS AND PATIENT/CAREGIVERS TO ASSESS THEIR KNOWLEDGE AND ATTITUDES ON PRESCRIBING AND HOME ADMINISTRATION CONDITIONS OF VELAGLUCERASE ALPHA (VPRIV®) IN 6 EUROPEAN COUNTRIES
IRAS ID
262375
Contact name
Derralynn Hughes
Contact email
Sponsor organisation
IQVIA
Duration of Study in the UK
0 years, 5 months, 15 days
Research summary
VPRIV® is used for the long-term treatment of patients with Gaucher disease. Gaucher disease is a rare inherited disorder, in which people do not have enough of glucocerebrosidase, which normally breaks down glucocerebroside.
The European Commission granted a marketing authorisation valid throughout the European Union for VPRIV® on 26 August 2010. (1) As VPRIV® is used as home infusion, EMA has asked Shire for additional risk minimization measures (educational material) to address the risk of serious hypersensitivity/allergic reactions occurring in the home setting with VPRIV®.
To measure the effectiveness of the educational material, Shire Pharmaceuticals will conduct a prescriber survey as part of the risk management plan for VPRIV® in the EU.
REC name
Social Care REC
REC reference
19/IEC08/0018
Date of REC Opinion
25 Apr 2019
REC opinion
Unfavourable Opinion