Jylamvo – a 2 mg/ml oral solution of methotrexate - was granted a European Union (Centralised) Marketing Authorisation in March 2017.
To see the announcement of the EMA’s grant of the Jylamvo marketing authorisation, click here
Jylamvo is licensed for use in adults and children over 3 years old for the treatment of rheumatological disorders (adult and juvenile) and adult psoriasis and psoriatic arthritis, and for the maintenance treatment of acute lymphoblastic leukaemia (ALL). It is the first oral liquid formulation of methotrexate to be authorised in Europe for the treatment of polyarthritic juvenile idiopathic arthritis (JIA).
Therakind was responsible for the complete development programme of Jylamvo and will retain the marketing authorisation and market the product throughout Europe via agreements with distribution partners.
For more information on Jylamvo, please click here
Therakind secured fast track marketing approval status from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for an intranasal paediatric pain control product, a collaborative project with Wockhardt UK Ltd. In addition, Therakind conducted two clinical studies in support of the marketing authorisation application which was approved in October 2013.