Therakind抗炎药Jylamvo（甲氨蝶呤，2mg/mL口服液）获欧盟CHMP支持批准
2017年2月3日，欧洲制药公司Therakind开发一款抗炎药Jylamvo（甲氨蝶呤，2毫克/毫升口服液）近日获得了欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的积极意见。CHMP建议批准Jylamvo，用于风湿疾病（成人和3岁以上儿童）和银屑病的治疗，以及用于急性淋巴细胞白血病（ALL）的维持治疗。
欧盟委员会（EC）在做出最终审查决定时通常都会采纳CHMP的建议，这也意味着Jylamvo很有可能在未来2-3个月获批在欧盟上市。
Jylamvo是一种口服液，与市面上的参考药物具有相同的活性药物成分——甲氨蝶呤（MTX），但Jylamvo作为一种口服配方的甲氨蝶呤溶液，其优势是可以很容易地通过口服给药并且很容易地进行剂量调整。与参考药物一样，Jylamvo的临床益处包括减少类风湿性关节炎、重度幼年特发性关节炎、银屑病、银屑病关节炎的症状，以及持续抑制白血病细胞的恶性增殖。
风湿疾病和银屑病均为慢性炎症性疾病，能对患者的生活能力带来严重困扰，而急性淋巴细胞白血病（ALL）是一种毁灭性的血液疾病。当患者面临这些疾病时，更容易服药的优势应该被充分考虑。Jylamvo作为一种口服液，其主要的用药对象将是那些吞咽药片有困难的幼儿患者群体和老年患者群体，同时给药的剂量能够很容易地进行调整。如果获批，Jylamvo将成为欧洲获批用于治疗幼年型关节炎的首个口服液配方的甲氨蝶呤
原始出处：EMA announces positive opinion for Jylamvo, Therakind’s 2 mg/ml oral solution of methotrexate
EMA announces positive opinion for Jylamvo, Therakind’s 2 mg/ml oral solution of methotrexate
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.”
This article Department of pharmacists/medical experts original translation finishing, welcome to reprint! At the same time the procurement of domestic scientific research institutions can contact us: 2363244352.3330889895