In March 2019, the small molecule brexanolone was approved by the United States Food and Drug Administration (FDA) for the treatment of postpartum depression (PPD) in adult women.[1] Brexanolone, developed by Sage Therapeutics under a license from the University of California, was granted priority review status and breakthrough therapy designation by the FDA.[2][3] Continue reading “Brexanolone (Zulresso™): First Global Approval – First approved therapy for postpartum depression”
Tag: First global approval
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]
Tagraxofusp (Elzonris™): First Global Approval – Breakthrough therapy for BPDCN and novel CD123-targeted therapy
The recent first global approval of tagraxofusp (Elzonris™) 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].
In December 2018, tagraxofusp, developed by Stemline Therapeutics, was approved by the United States Food and Drug Administration (FDA) for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and children 2 years and older.[1][3] Continue reading “Tagraxofusp (Elzonris™): First Global Approval – Breakthrough therapy for BPDCN and novel CD123-targeted therapy”
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”
Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine
Erenumab (AIMOVIG™, erenumab-aooe) was launched in the US in July 2018, following its first global approval in the region in May, which was reviewed in detail in the First Global Approval report in Adis’ journal Drugs[1], based on the development milestones tracked in AdisInsight[2]. Also in May 2018, the agent received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). Continue reading “Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine”
Anlotinib (Focus V®): First Global Approval – single-drug 3rd-line therapy for patients with advanced recurrent NSCLC
The recent first global approval of anlotinib 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].
In May 2018, anlotinib (Focus V®), co-developed by Jiangsu Chia-Tai Tianqing Pharmaceutical and Advenchen Laboratories, received its first global approval in China as a single drug therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have undergone progression or recurrence after ≥ 2 lines of systemic chemotherapy. Continue reading “Anlotinib (Focus V®): First Global Approval – single-drug 3rd-line therapy for patients with advanced recurrent NSCLC”
Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding
The recent first global approval of andexanet alfa [coagulation factor Xa (recombinant), inactivated-zhzo] 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 “Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding”
Fostamatinib (TAVALISSE™): First Global Approval – initiating the fight against self-destruction in patients with ITP
The recent first global approval of fostamatinib 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 “Fostamatinib (TAVALISSE™): First Global Approval – initiating the fight against self-destruction in patients with ITP”
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”
Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia
The recent first global approval of burosumab 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 “Burosumab (Crysvita®): First Global Approval – Infrastructure repair for patients with X-linked hypophosphataemia”