Arthritis Drugs Get Nod From EMA's CHMP

Megan Brooks

Disclosures

January 27, 2017

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of several drugs for rheumatoid arthritis (RA) and other conditions, such as Crohn's disease, at its January meeting held this week.

The committee recommended approval of tofacitinib citrate (Xeljanz, Pfizer) in combination with methotrexate (MTX) for the treatment of adults with moderate to severe active RA who have not responded adequately to or who are intolerant of one or more disease-modifying antirheumatic drugs.

Tofacitinib is a selective Janus kinase inhibitor approved in over 50 countries. It will be available in 5-mg film-coated tablets.

The drug can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. Treatment should be started and supervised by physicians experienced in the diagnosis and treatment of RA, the CHMP said.

Biosimilars

The committee also recommended approval of two adalimumab (Humira, AbbVie) biosimilar drugs: Amgevita and Solymbic, both from Amgen Europe BV.

Amgevita is for the treatment of RA, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, and uveitis.

Solymbic is intended for the treatment of RA, enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis, and uveitis.

Amgevita and Solymbic are "highly similar" to the reference product Humira, which was approved in the European Union in 2003, and have "comparable quality, safety and efficacy to Humira," the committee said.

Both Amgevita and Solymbic will be available as a solution for injection (20 and 40 mg).

Jylamvo

The committee also recommended the MTX hybrid drug Jylamvo (Therakind Ltd) for the treatment of rheumatologic disorders and psoriasis (and for the maintenance treatment of acute lymphoblastic leukemia). Jylamvo will be available as an oral solution (2 mg/mL).

Jylamvo is a hybrid medicine of Methotrexat "Lederle" 25 mg-Stechampulle and Methotrexate "Lederle" 2.5-mg tablets, which have been approved in the in the European Union since 1984 and 1959, respectively.

"Jylamvo contains the same active substance as these reference medicines but is given by mouth as a solution. Studies have demonstrated the satisfactory quality of Jylamvo and its bioequivalence to Methotrexate "Lederle" 2.5 mg tablets and a third product, Ebetrexat 10 mg tablets which is authorized in similar indications," the committee said.

Hybrid drug applications rely in part on the results of preclinical tests and clinical trials for a reference product and in part on new data, they note.

The CHMP's opinions will now be sent to the European Commission for final decision.

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