A Medscape article today announces that Mirvaso has been granted human approval and should be approved for sale across Europe by March 2014.
The initial authorisation to market Mirvaso has been granted and are normally issued 67 days from the adoption of the `Summary of opinion’
Miriam E. Tucker
December 20, 2013
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended marketing of brimonidine tartrate 3 mg/g topical gel (Mirvaso, Galderma) for the symptomatic treatment of facial erythema of rosacea in adult patients.
“The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for Mirvaso and therefore recommends the granting of the marketing authorization,” the committee said in a statement.
The CHMP is the committee at the European Medicines Agency that is responsible for preparing opinions on questions concerning medicines for human use.
The announcement mentions that Mirvaso will be subject to a pharmacovigilance plan where adverse events will be collected and analysed.
The most common local adverse events associated with topical use of brimonidine tartrate are erythema, pruritus, flushing, and skin burning sensation. A pharmacovigilance plan for the product will be implemented as part of the marketing authorization.
This is a good development because as we have been in the later half of 2013, the online reports from users of Mirvaso do not match the efficacy and safety of the Phase 3 Trials.
It is still unclear why this appears to be so, but many adverse reactions, often described as rebound flushing are being reported, seemingly in a much greater frequency that the around 5% seen in the large scale trial participants.
Perhaps some more insight into adverse reactions to Mirvaso will surface as safety data is collected on a wider scale.
When will Mirvaso be available in Europe?
Detailed recommendations for brimonidine’s use will be published in the European public assessment report and made available in all official European Union languages after the marketing authorization has been granted by the European Commission, which is expected within 67 days.
If you take December 20 as the CHMP approval, then 67 days later brings us to near the beginning of March 2014.
Marketing authorisation, as recommended by the CHMP is “approval to market a medicine in one, several or all European Union Member States”.