EMA announces positive opinion for Jylamvo, Therakind’s 2 mg/ml oral solution of methotrexate

27th January 2017

Jylamvo will be licensed throughout Europe for use in adults and children over 3 years old once the opinion is adopted

Jylamvo will be the first oral liquid formulation of methotrexate to be authorised in Europe for use in the treatment of juvenile arthritis

Therakind is pleased to report that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) today announced that it has adopted a positive opinion, recommending the granting of a marketing authorisation for Therakind’s Jylamvo (methotrexate 2mg/ml oral solution) for the treatment of rheumatological disorders (adult and juvenile) and psoriasis, and for the maintenance treatment of acute lymphoblastic leukaemia (ALL).

Jylamvo’s benefits include the ability to reduce the symptoms of rheumatoid arthritis, severe juvenile idiopathic arthritis, psoriasis and psoriatic arthritis and to exert a sustained effect on malignant growth in ALL.

As a hybrid medicine of methotrexate, Jylamvo contains the same active substance as reference medicines which have already been authorised in the European Union (EU) but Jylamvo is given by mouth as an oral solution. The positive opinion covers use in adults and in children aged three years and over.

Once the positive opinion has been formally adopted by the European Commission (decision is normally issued 67 days from adoption of the opinion), Jylamvo will be granted a centralized marketing authorisation for use in all 28 Member States of the EU as well as the countries in the European Economic Area (EEA) (Norway, Iceland and Liechtenstein).

Dr Susan Conroy, Therakind’s CEO remarked,

“Rheumatological disorders and psoriasis are chronic conditions which can significantly impact on people’s ability to live their lives, and ALL is a devastating illness. When patients are faced with such conditions, the benefit of taking the medicine more easily should not be discounted. Jylamvo was formulated as an oral solution primarily so that young children and older adults who often have difficulty swallowing tablets would have access to a licensed oral liquid form of methotrexate, as well as making dosing adjustment easier.

Therakind are therefore delighted at this positive opinion, the breadth of which will mean Jylamvo can be licensed Europe-wide for use in both children and adults.  Jylamvo will be the first oral liquid formulation of methotrexate to be authorised in Europe for use in the treatment of juvenile arthritis.”

A summary of the CHMP opinion can be found here