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”

Erenumab (AIMOVIG™): First Global Approval in US followed by Positive CHMP Opinion – Once-monthly prophylactic approach for adults with Migraine

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”

Andexanet Alfa (Andexxa ®): First Global Approval – first-in-class anticoagulant rescue for therapy-induced bleeding

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”

Enasidenib (Idhifa®): First Global Approval – first-in-class, precision therapy for patients with mutated AML

Enasidenib (Idhifa®): First Global Approval – first-in-class, precision therapy for patients with mutated AML

The recent first global approval of enasidenib 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 “Enasidenib (Idhifa®): First Global Approval – first-in-class, precision therapy for patients with mutated AML”

Guselkumab (Tremfya™): First Global Approval – first-in-class biologic treatment option for adult plaque psoriasis

Guselkumab (Tremfya™): First Global Approval – first-in-class biologic treatment option for adult plaque psoriasis

The recent first global approval of guselkumab 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 “Guselkumab (Tremfya™): First Global Approval – first-in-class biologic treatment option for adult plaque psoriasis”

Ocrelizumab (Ocrevus™): First Global Approval – making a B-line to crushing the most aggressive form of MS

Ocrelizumab (Ocrevus™): First Global Approval – making a B-line to crushing the most aggressive form of MS

The recent first global approval of ocrelixumab 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 “Ocrelizumab (Ocrevus™): First Global Approval – making a B-line to crushing the most aggressive form of MS”

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”