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 was pivotal in the process of bringing to market Buccolam®, a treatment for prolonged acute convulsive seizures in children. Buccolam® was granted the first European Paediatric Use Marketing Authorisation (PUMA) by the European Commission. Therakind was responsible for the regulatory development strategy (securing agreement of a Paediatric Investigation Plan) as well as the design, management and sponsoring of the clinical trial. This product was sold in 2010 to Viropharma Inc (subsequently acquired by Shire Pharmaceuticals) and is being marketed across Europe.
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.