Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan

Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan

Durvalumab (IMFINZI®) was approved by the Japanese Ministry of Health, Labour and Welfare in July 2018, for maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC).[1] Continue reading “Durvalumab (IMFINZI®): Follow up Approval for NSCLC in Japan”

Baloxavir Marboxil (XOFLUZA™): First Global Approval – a One-Pill Wonder for Patients with Influenza

Baloxavir Marboxil (XOFLUZA™): First Global Approval – a One-Pill Wonder for Patients with Influenza

The recent first global approval of baloxavir marboxil 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].

Japan was first country to approve baloxavir marboxil (XOFLUZA™) in February 2018, under Sakigake fast track review. The agent is being jointly developed by Shionogi and Roche and was approved for the treatment of influenza types A and B in paediatric and adult patients. Continue reading “Baloxavir Marboxil (XOFLUZA™): First Global Approval – a One-Pill Wonder for Patients with Influenza”

Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.

Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.

In November 2017, benralizumab (Fasenra™), developed by Kyowa Hakka Kirin & AstraZeneca, received its first global approval in the USA as add-on maintenance therapy for patients with severe eosinophilic asthma who are at least 12 years old. [1][2] Continue reading “Benralizumab (Fasenra™): First Global Approval – eosinophil depletion and a convenient maintenance regimen for patients with severe asthma.”

Sarilumab (Kevzara™): Follow up Approval in Japan

Sarilumab (Kevzara™): Follow up Approval in Japan

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

In September 2017, sarilumab (Kavzara™) was also approved in Japan for the treatment of adult patients with rheumatoid arthritis who have had an inadequate response to conventional treatments[1].

This approval is in addition to those already granted earlier this year in the US and Europe.

For further information related to the first approval of sarilumab please visit Drugs, or to learn more about the overall development of sarilumab across all indications visit AdisInsight.

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!

The recent first global approval of glecaprevir/pibrentasvir 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 “Glecaprevir/Pibrentasvir (MAVIRET™): First Global Approval in Europe – then BAM! Anti-viral approval spreads rapidly across the globe!!”

Pemafibrate (Parmodia®): First Global Approval – second (PPAR)-α agonist joins Japanese market in a bid to tip the lipoprotein cholesterol balance

Pemafibrate (Parmodia®): First Global Approval –  second (PPAR)-α agonist joins Japanese market in a bid to tip the lipoprotein cholesterol balance

The recent first global approval of pemafibrate 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 “Pemafibrate (Parmodia®): First Global Approval – second (PPAR)-α agonist joins Japanese market in a bid to tip the lipoprotein cholesterol balance”