Bictegravir, in combination with emtricitabine and alafenamide (Biktarvy ®) received its first global approval in the US in February 2018. Subsequently, in April, this fixed-dose triple combination has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA).
The recent first global approval of bictegravir has been reviewed in detail in the First Global Approval report in Adis’ journal Drugs, based on the development milestones tracked in AdisInsight. Bictegravir (Biktarvy®), developed by Gilead Sciences, received its first global approval in February 2018 in the USA as a fixed-dose combination, with emtricitabine and tenofovir … Continue reading Bictegravir (Biktarvy®): First Global Approval – an all-in-one package: A single-tablet HIV-1 treatment regimen
Baricitinib was first approved in the EU in February 2017 for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA); this was followed shortly after by an approval in Japan in July of the same year. Almost a year later, this Janus Kinase (JAK) inhibitor was approved by the US FDA in June 2018.