Ministry of Health, Labour and Welfare

Takeda Announces Approval of Nuvaxovid® COVID-19 Vaccine for Primary and Booster Immunization in Japan

Retrieved on: 
Tuesday, April 19, 2022

Takeda (TSE:4502/NYSE:TAK) today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.

Key Points: 
  • Takeda (TSE:4502/NYSE:TAK) today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older.
  • Takeda will begin distribution of Nuvaxovid doses purchased by the Government of Japan as soon as possible.
  • Additional safety and efficacy data were submitted to support booster immunization, including a Phase 2 study conducted by Novavax in South Africa evaluating a booster dose given 6 months after primary immunization.
  • Nuvaxovid is stored at a refrigerated temperature of 2 -8 and will be transported using a conventional vaccine supply chain.

SB623 Demonstrated Sustained Improvement in Motor Impairment up to 48 Weeks and Associated with Improvement in Function and Activities of Daily Living in Patients with Chronic Traumatic Brain Injury

Retrieved on: 
Tuesday, April 5, 2022

These findings reinforce the potential for SB623 to provide clinically meaningful improvements in motor function and ability to resume daily activities.

Key Points: 
  • These findings reinforce the potential for SB623 to provide clinically meaningful improvements in motor function and ability to resume daily activities.
  • These improvements in motor impairment were maintained up to 48 weeks in the treatment group.
  • SanBio is preparing to initiate a Phase 3 trial for SB623 in the United States, where many traumatic brain injury patients currently live.
  • SB623 is currently being investigated for the treatment of several conditions including chronic neurological motor deficit resulting from traumatic brain injury and ischemic stroke.

Jyseleca® approved in Japan for ulcerative colitis

Retrieved on: 
Monday, March 28, 2022

(Tokyo, Japan), Eisai Co., Ltd. (Tokyo, Japan) and EA Pharma Co., Ltd. (Tokyo, Japan) today announced the approval by the Japanese Ministry of Health, Labour and Welfare (MHLW), of a second indication for Jyseleca (filgotinib), a once-daily, oral, JAK1 preferential inhibitor, for the treatment of patients with moderate-to-severe active ulcerative colitis (UC).

Key Points: 
  • (Tokyo, Japan), Eisai Co., Ltd. (Tokyo, Japan) and EA Pharma Co., Ltd. (Tokyo, Japan) today announced the approval by the Japanese Ministry of Health, Labour and Welfare (MHLW), of a second indication for Jyseleca (filgotinib), a once-daily, oral, JAK1 preferential inhibitor, for the treatment of patients with moderate-to-severe active ulcerative colitis (UC).
  • The approval of this second indication for Jyseleca in Japan is based on data from the randomized, double-blind, placebo-controlled phase 2b/3 SELECTION study.
  • Jyseleca was approved in Japan in September 2020 for the treatment of rheumatoid arthritis (RA), including the prevention of structural joint damage, in patients who had inadequate response to conventional therapies.
  • Gilead Japan will hold the marketing authorization of Jyseleca in Japan and will be responsible for product supply.

Eisai Initiates Submission of Application Data Under the Prior Assessment Consultation System in Japan with the Aim of Obtaining Early Approval for Investigational Anti-Amyloid Beta Protofibril Antibody Lecanemab

Retrieved on: 
Friday, March 4, 2022

By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.

Key Points: 
  • By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
  • The prior assessment consultation is conducted at the development stage before new drug application submission based on available quality, non-clinical and clinical data.
  • By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
  • Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic.

argenx Reports Full Year 2021 Financial Results and Provides Fourth Quarter Business Update

Retrieved on: 
Thursday, March 3, 2022

VYVGART (efgartigimod alfa-fcab) approved in the U.S. and Japan as the first-and-only neonatal Fc receptor (FcRn) blocker; U.S. commercial launch underway

Key Points: 
  • VYVGART (efgartigimod alfa-fcab) approved in the U.S. and Japan as the first-and-only neonatal Fc receptor (FcRn) blocker; U.S. commercial launch underway
    Breda, the Netherlands argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today reported financial results for the full year 2021 and provided a fourth quarter business update.
  • 2021 was a transformational year for argenx, culminating with the FDA approval of VYVGART, our first-in-class FcRn blocker, in December.
  • We carried this momentum into 2022 with the official U.S. launch of VYVGART and the Japan approval.
  • In addition to executing the global commercial launch of VYVGART, we are primed to deliver several upcoming catalysts through our development pipeline in high-value autoimmune indications.

Eisai initiates submission of application data of lecanemab under the prior assessment consultation system in Japan with the aim of an earlier regulatory approval

Retrieved on: 
Friday, March 4, 2022

The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data.

Key Points: 
  • The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data.
  • By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
  • The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA.
  • Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease.

Eisai initiates submission of application data of lecanemab under the prior assessment consultation system in Japan with the aim of an earlier regulatory approval

Retrieved on: 
Friday, March 4, 2022

The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data.

Key Points: 
  • The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data.
  • By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.
  • The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA.
  • Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease.

Reata Pharmaceuticals Receives Complete Response Letter From The FDA for Bardoxolone for the Treatment of Patients with Chronic Kidney Disease Caused by Alport Syndrome

Retrieved on: 
Friday, February 25, 2022

Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (Reata, the Company, or we), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for bardoxolone methyl (bardoxolone) for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome.

Key Points: 
  • Reata Pharmaceuticals, Inc. (Nasdaq: RETA) (Reata, the Company, or we), today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for bardoxolone methyl (bardoxolone) for the treatment of patients with chronic kidney disease (CKD) caused by Alport syndrome.
  • This outcome is a significant disappointment for our company, as well as the many patients, families, and investigators who have participated in our development program for bardoxolone in Alport syndrome patients.
  • According to the Alport Syndrome Foundation, Alport syndrome affects approximately 30,000 to 60,000 people in the United States.
  • The FDA and European Commission have granted Orphan Drug designation to bardoxolone for the treatment of Alport syndrome and autosomal dominant polycystic kidney disease (ADPKD).

Akebia Therapeutics Announces Amendment of License Agreement with Vifor Pharma in Preparation for Potential Vadadustat Launch

Retrieved on: 
Tuesday, February 22, 2022

The new agreement further supports Akebia's commercialization strategy ahead of a potential first-in-class U.S. launch for vadadustat which, as previously noted, provides access to up to 60% of U.S. dialysis patients through existing Vifor Pharma relationships.

Key Points: 
  • The new agreement further supports Akebia's commercialization strategy ahead of a potential first-in-class U.S. launch for vadadustat which, as previously noted, provides access to up to 60% of U.S. dialysis patients through existing Vifor Pharma relationships.
  • The new agreement further expands this license to also include additional independent dialysis organizations.
  • In consideration for the extension of Vifor Pharma's customer group, Vifor Pharma agreed to an additional equity purchase of $20 million.
  • Under the terms of the amended and restated agreement, Vifor Pharma will accelerate payment of the previously agreed upon $25 million milestone to Akebia.

FDA Approves SPIKEVAX®, Moderna's mRNA COVID-19 Vaccine

Retrieved on: 
Tuesday, February 1, 2022

"This approval indicates that the vaccine has met the FDA's rigorous standards for safety, effectiveness and manufacturing quality required for approval."

Key Points: 
  • "This approval indicates that the vaccine has met the FDA's rigorous standards for safety, effectiveness and manufacturing quality required for approval."
  • Conceptually distinct from other approved COVID-19 vaccine brand names, SPIKEVAX refers to the "spike" glycoprotein, one of the key characteristics of SARS-CoV-2.
  • The mRNA vaccine, SPIKEVAX, gives instructions for cells to produce copies of the "spike" protein, which subsequently becomes a target for the generation of neutralizing antibodies against it.
  • "SPIKEVAX has many of the name characteristics and attributes we pursue when creating a new pharmaceutical or vaccine brand name."