This Mabthera approval provides a much needed new
treatment that has been shown to provide higher remission rates than corticosteroids alone, which can cause debilitating side effects.”.
Mabthera is the first biologic therapy approved
by the European Commission for PV and the first major advancement in the treatment of the disease in more than 60 years.
Following approval by the US Food and Drug Administration(FDA)
in June 2018 and current decision, Mabthera is now approved to treat four autoimmune diseases in the US and Europe.
Following approval by the US Food and Drug Administration(FDA)
in June 2018 and today's decision, Mabthera is now approved to treat four autoimmune diseases in the US and Europe.
On March 15,
2019 European Commission has approved Roche's Mabthera®(rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris(PV),
a rare condition characterized by progressive painful blistering of the skin and/or mucous membranes.
On March 15, 2019,
Roche announced that the European Commission has approved Mabthera®(rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris(PV),
a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes.