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”

Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection

Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection

The recent first global approval of Ibalizumab has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2].

Ibalizumab (Trogarzo™) developed by TaiMed Biologics received its first global approval in March 2018 in the US for the treatment of heavily treatment-experienced patients with multidrug resistant HIV-1 infection in combination with other antiretroviral medicines. Continue reading “Ibalizumab (Trogarzo™): First Global Approval – Blocking HIV entry to CD4 cells may open options for combination therapy in patients with multi-resistant HIV infection”

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer

The recent first global approval of abemaciclib has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Continue reading “Abemaciclib (Verzenio™) First Global Approval – Early decision by FDA for new continuous treatment option for metastatic breast cancer”

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”