Astellas Pharma’s Smyraf (ingredient: peficitinib) obtained regulatory approval for the treatment of rheumatoid arthritis. Smyraf is the third oral Janus kinase (JAK) inhibitor to receive approval after Xeljanz (tofacitinib) and Olumiant (baricitinib).

The Ministry of Food and Drug Safety has recently authorized the drug to be used for rheumatoid arthritis patients with inadequate response to disease-modifying antirheumatic drugs (DMARDs).

Smyraf is a pan-JAK inhibitor that reduces joint inflammation and pain by suppressing the kinases such as JAK-1, JAK-2, JAK-3 and tyk-2 (tyrosine kinase 2) involved in inflammatory cytokine signaling pathways. Patients can take Smyraf 100 mg once a day after meals.

The grant of the license was supported by two phase-3 trials – RAJ3 and RAJ4. In the studies, Smyraf demonstrated superior effect regarding the ACR20 response rate at week 12 as the primary endpoint, compared to the placebo. ACR is an evaluation measure by the American College of Rheumatology.

“Rheumatoid arthritis requires long-term treatment, which is why drug tolerability and ease of use are important. In this view, Smyraf has shown excellent tolerability in studies on Asian patients,” Astellas Pharma Korea said in a press release. “RAJ3 and RAJ4 studies did not report any venous thromboembolism (VTE). Once-daily dose made it easier for patients to take the drug.”

Astellas Pharma Korea also sells another rheumatoid arthritis drug Prograf (tacrolimus). With the release of Smyraf, the company said it would enhance sales of rheumatoid arthritis treatments.

kym@docdocdoc.co.kr

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