Roxadustat (Ai Rui Zhuo® in China): First Global Approval – First-in-class small molecule for anaemia in patients with DD-CKD

Roxadustat (Ai Rui Zhuo® in China): First Global Approval – First-in-class small molecule for anaemia in patients with DD-CKD

In December 2018, roxadustat, developed by FibroGen, in collaboration with Astellas and AstraZeneca, received its first global approval in China for the treatment of anaemia in patients with dialysis-dependent chronic kidney disease (DD-CKD).[1] Roxadustat is expected to launch in China in the second half of 2019.[2]

Continue reading “Roxadustat (Ai Rui Zhuo® in China): First Global Approval – First-in-class small molecule for anaemia in patients with DD-CKD”

Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease

Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease

Avatrombopag (Doptelet ®) received its first global approval in the US; this was 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 “Avatrombopag (Doptelet®): First Global Approval – Reducing the bleeding risks of invasive procedures in patients with Chronic Liver Disease”

Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome

Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome

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

Continue reading “Telotristat Ethyl (Xermelo™): First Global Approval – first and only oral drug for cancer-related diarrhoea syndrome”

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”

Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication

Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication

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

In December 2016, Rucaparib (Rubraca™), developed by Clovis Oncology, Inc., received its first global approval in the USA for the treatment of ovarian cancer, specifically as monotherapy for the treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.1 A marketing authorisation application for rucaparib for the same indication has been submitted to the European Medicines Agency. Continue reading “Rucaparib (Rubraca™): First Global Approval – further improves personalised cancer care in high-need indication”