MHLW

AmoyDx® Pan Lung Cancer PCR Panel Approved in Japan as a Companion Diagnostic for selpercatinib RET fusion positive NSCLC

Retrieved on: 
Monday, March 27, 2023

The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of activation alterations in 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes) when all genes on the panel are approved as companion diagnostics.

Key Points: 
  • The AmoyDx® PLC Panel is based on polymerase chain reaction (PCR) technology and can simultaneously evaluate the presence of activation alterations in 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes) when all genes on the panel are approved as companion diagnostics.
  • The AmoyDx® PLC Panel has received approval for the identification of activating alterations in seven driver genes (EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, KRAS, and RET) for twelve (12) associated targeted therapies in NSCLC.
  • With its high sensitivity and short turnaround time, the AmoyDx® PLC Panel is expected to be an important clinical diagnostic in guiding treatment opportunities for NSCLC patients.
  • “With this approval, the AmoyDx® PLC Panel can now be used to identify RET fusion-positive NSCLC patients for treatment with selpercatinib, thereby expanding their therapeutic options.

Incyte Announces Japanese Approval of Pemazyre® (pemigatinib) for the Treatment of Patients with Myeloid/Lymphoid Neoplasms (MLNs)

Retrieved on: 
Monday, March 27, 2023

“The MHLW approval of Pemazyre in MLNs is an important step toward potentially providing a therapeutic option for Japanese patients with this rare condition,” said Lothar Finke, M.D., Ph.D., Group Vice President and General Manager, Incyte Asia.

Key Points: 
  • “The MHLW approval of Pemazyre in MLNs is an important step toward potentially providing a therapeutic option for Japanese patients with this rare condition,” said Lothar Finke, M.D., Ph.D., Group Vice President and General Manager, Incyte Asia.
  • The primary endpoint, investigator-assessed complete response rate, was 62.5% (95% CI: 45.8 - 77.3).
  • The most common adverse reactions observed in patients receiving Pemazyre were hyperphosphatemia (70.7%), alopecia (56.1%), diarrhea (43.9%) and stomatitis (43.9%).
  • Designated orphan drugs are also eligible for priority review for marketing authorizations to ensure supply to clinical settings at the earliest opportunity1.

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Tuesday, February 28, 2023

TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.

Key Points: 
  • TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
Monday, February 27, 2023

In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.

Key Points: 
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

Darolutamide receives approval for additional prostate cancer indication in Japan

Retrieved on: 
Monday, February 27, 2023

The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.

Key Points: 
  • The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of metastatic prostate cancer.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • Darolutamide is being investigated in a broad development program with three additional ongoing or planned large clinical studies, to evauate its potential across prostate cancer patients from the early- to the late-stage of this disease.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.

Shionogi Presents Pivotal Ensitrelvir Fumaric Acid Phase 3 Data and Exploratory Long COVID Data at CROI

Retrieved on: 
Tuesday, February 21, 2023

Shionogi also presented exploratory data from the Study evaluating the potential effect of ensitrelvir on the symptoms of long COVID.

Key Points: 
  • Shionogi also presented exploratory data from the Study evaluating the potential effect of ensitrelvir on the symptoms of long COVID.
  • Regarding safety, ensitrelvir was well tolerated, and there were no serious treatment-related adverse events or deaths in the Study.
  • “A treatment addressing the symptoms of long COVID remains one of the largest unmet needs of the pandemic.
  • "As these data are from an exploratory analysis, this promising signal will hopefully be followed up with further evaluation of ensitrelvir for long COVID.”

Shionogi Advances Ensitrelvir Fumaric Acid COVID-19 Antiviral Clinical Program

Retrieved on: 
Wednesday, February 15, 2023

Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced progress on its comprehensive clinical development program for the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.

Key Points: 
  • Shionogi & Co., Ltd. (Head Office: Osaka, Japan; Chief Executive Officer: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced progress on its comprehensive clinical development program for the novel COVID-19 oral antiviral ensitrelvir (Generic name: ensitrelvir fumaric acid, Code No.
  • The program includes several Phase 3 clinical studies evaluating ensitrelvir’s safety and effectiveness across a wide range of COVID-19 patient populations.
  • Ensitrelvir is the first drug to be evaluated in the STRIVE program, a new agile research approach set up to rapidly assess interventions during epidemics adversely affecting public health.
  • Pediatric Trial: Shionogi plans to initiate a Phase 3 pediatric study evaluating the safety and effectiveness of ensitrelvir for children ages 6-12 in Japan, starting in early 2023.

Brand Institute's Vice President of Creative Nomenclature Explains the Pharmaceutical Brand Name Review Process Used by Japanese Regulators

Retrieved on: 
Tuesday, January 31, 2023

Pharmaceutical manufacturers will submit brand name proposals to a health agency for review, and that agency will assess those names for similarity to existing brand names in that country or region.

Key Points: 
  • Pharmaceutical manufacturers will submit brand name proposals to a health agency for review, and that agency will assess those names for similarity to existing brand names in that country or region.
  • If a name is too similar to another name based on that agency's guidelines, the proposed brand name may be rejected.
  • "In Japan, the brand name review process is much different," said Sanae Suga, Brand Institute's Vice President of Creative Nomenclature.
  • English brand names are transliterated into katakana, a component of the Japanese writing system.

Lecanemab Receives Priority Review Status in Japan

Retrieved on: 
Sunday, January 29, 2023

Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.

Key Points: 
  • Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.
  • In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.

Akron Bio Receives Eligibility Confirmation from PMDA in Japan for the Commercialization of Virus Inactivated Human Fibronectin in Clinical Cell Therapy Manufacturing

Retrieved on: 
Tuesday, January 17, 2023

Akron Bio (“Akron”), a leading supplier of critical inputs for cell and gene therapies, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted Akron Eligibility Confirmation for its cGMP Virus Inactivated Human Fibronectin.

Key Points: 
  • Akron Bio (“Akron”), a leading supplier of critical inputs for cell and gene therapies, today announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted Akron Eligibility Confirmation for its cGMP Virus Inactivated Human Fibronectin.
  • Akron's Virus Inactivated Human Fibronectin has been on the market for nearly a decade and is a top choice for facilitating the attachment and proliferation of different anchorage-dependent cells during cell therapy manufacturing.
  • This eligibility confirmation from the Japanese regulatory authorities is another example of Akron products being recognized by regulatory authorities as safe and compliant.
  • Akron’s Virus Inactivated Human Fibronectin is manufactured, tested, and released following relevant cGMP guidelines for ancillary materials and is specifically formulated for cell therapy manufacturing applications.