Baricitinib (Olumiant™): Now also available in the USA

Baricitinib (Olumiant™): Now also available in the USA

Baricitinib was first approved in the EU in February 2017 for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA);[1] this was followed shortly after by an approval in Japan in July of the same year.[2] Almost a year later, this Janus Kinase (JAK) inhibitor was approved by the US FDA in June 2018.[3] Continue reading “Baricitinib (Olumiant™): Now also available in the USA”

Sarilumab (Kevzara™): Follow up Approval in Japan

Sarilumab (Kevzara™): Follow up Approval in Japan

The first global approval of sarilumab in Canada has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In September 2017, sarilumab (Kavzara™) was also approved in Japan for the treatment of adult patients with rheumatoid arthritis who have had an inadequate response to conventional treatments[1].

This approval is in addition to those already granted earlier this year in the US and Europe.

For further information related to the first approval of sarilumab please visit Drugs, or to learn more about the overall development of sarilumab across all indications visit AdisInsight.

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis

AdisInsightThe recent first global approval of sarilumab has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In February 2017, sarilumab (Kevzara™), developed by Sanofi and Regeneron Pharmaceuticals, received its first global approval in Canada for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more biologic or non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Continue reading “Sarilumab (Kevzara™): First Global Approval – an alternative MOA to TNF agents for rheumatoid arthritis”

Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment

Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment

The recent first global approval of Baricitinib has been reviewed in detail in the First Global Approval report in Adis journal Drugs, based on the development milestones tracked in AdisInsight.

In February 2017, baricitinib (Olumiant™), developed by Eli Lily and Incyte Corporation, received its first global approval in the EU as monotherapy or in combination with methotrexate, for the treatment of moderate to severe rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Continue reading “Baricitinib (Olumiant™): First Global Approval – daily oral formulation may win patient preference for next-gen RA treatment”