CHMP

CHMP issues positive opinions for both bempedoic acid and the bempedoic acid / ezetimibe fixed-dose combination tablet as treatments for hypercholesterolaemia and significantly reducing cardiovascular events

Retrieved on: 
Friday, March 22, 2024
Health, Biometrics, General Health, Clinical Trials, Pharmaceutical, Cardiology, Biotechnology, Hypercholesterolemia, European Commission, Bempedoic acid, Risk, Patient, Tablet, Committee, ACL, Ageing, Agent handling, Esperion Therapeutics, EMA, Death, European Medicines Agency, Ezetimibe, Therapy, Moyamoya disease, ATP, FDC, CHMP, Apolipoprotein, Pharmaceutical industry

“The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.

Key Points: 
  • “The positive CHMP opinion is a crucial milestone towards improved treatment outcomes, as we are now able to address even better the unmet needs of cardiovascular care and prevention among patients in Europe.
  • This first-in-class medicine with proven efficacy in reducing hypercholesterolaemia and preventing cardiovascular risks, is a testament to our tireless efforts to help improve the cardiovascular treatment landscape.
  • The CHMP is a scientific committee of the EMA that reviews medical product applications on their scientific and clinical merit.
  • The European Commission will review the CHMP opinions and is expected to deliver its final decision in the mid of the year 2024.

U.S. FDA Approves Broad New Labels for Esperion’s NEXLETOL® and NEXLIZET® to Prevent Heart Attacks and Cardiovascular Procedures in Both Primary and Secondary Prevention Patients, Regardless of Statin Use

Retrieved on: 
Friday, March 22, 2024
FDA, Health, Other Health, Pharmaceutical, Cardiology, Biotechnology, Photograph, Glucose, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, European Medicines Agency, Ezetimibe, Therapy, Anemia, Pain, Sinusitis, Esperion Therapeutics, Bempedoic acid, Abdominal pain, Risk, Gout, Webcast, Committee, Spasm, Splenic infarction, ESPR, Back pain, ATP, Safety, Membrane protein, Fatigue, CHMP, Arthralgia, Angioedema, U.S. FDA, Cardiovascular disease, Kidney, Constipation, Death, Adverse event, Pregnancy, CLEAR, Rash, Rupture, Molina Healthcare, Hypersensitivity, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Multimedia, Uric acid, Dietary supplement

In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.

Key Points: 
  • In addition, the enhanced labels support the use of NEXLETOL and NEXLIZET either alone or in combination with statins.
  • They also include new indications for primary hyperlipidemia, alone or in combination with a statin, and are the only LDL-C lowering non-statin drugs indicated for primary prevention patients.
  • View the full release here: https://www.businesswire.com/news/home/20240322544788/en/
    U.S. FDA approves broad new labels for NEXLETOL® (bempedoic acid) Tablets and NEXLIZET® (bempedoic acid and ezetimibe) Tablets to prevent heart attacks and cardiovascular procedures in both primary and secondary prevention patients, regardless of statin use.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

FDA Advisory Committee Votes in Favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy

Retrieved on: 
Friday, March 15, 2024
Biotechnology, FDA, Pharmaceutical, Health, Emory University, Multiple myeloma, BMY, Development, Survival, ASH, Disease, Oncology, Patient, FACP, Committee, EMA, Cell therapy, Bristol Myers Squibb, MD, Winship Cancer Institute, European Medicines Agency, Society, ODAC, CHMP, Food, Pharmaceutical industry

Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival.

Key Points: 
  • Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the pivotal Phase 3 KarMMa-3 study, including the key secondary endpoint of overall survival.
  • The recommendation from the ODAC will be considered by the FDA during its ongoing review of the supplemental Biologics License Application (sBLA) for Abecma for this patient population.
  • The FDA has not yet assigned a new target action date for review of the sBLA.
  • “With patients becoming triple-class exposed earlier in the multiple myeloma treatment paradigm, it is critical that new treatment options with the potential to improve long-term outcomes are available as early as possible,” said Sagar Lonial, MD, FACP, professor and chair, Department of Hematology & Medical Oncology, Emory University School of Medicine, chief medical officer, Winship Cancer Institute of Emory University.

Legend Biotech Reports Fourth Quarter and Full Year 2023 Results and Recent Highlights

Retrieved on: 
Monday, March 11, 2024
Research, FDA, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Oncology, Other Science, Johnson & Johnson, Growth, Drug discovery, Exercise, Partnership, Webcast, Patient, Committee, Collaboration, Nature, Senior, Lenalidomide, Investment, Investigational New Drug, Delta, ODAC, Janssen, CHMP, Food

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its fourth quarter and full year 2023 unaudited financial results and key corporate highlights.

Key Points: 
  • Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its fourth quarter and full year 2023 unaudited financial results and key corporate highlights.
  • Financial Results for Quarter and Year Ended December 31, 2023
    As of December 31, 2023, Legend Biotech had approximately $1.3 billion of cash and cash equivalents, time deposits, and short-term investments.
  • There was no license revenue for the three months ended December 31, 2023, and December 31, 2022.
  • License revenue for the year ended December 31, 2023, was $35.2 million, compared to $50.0 million for the year ended December 31, 2022.

Prilenia Plans to Submit Marketing Authorization Application (MAA) in the EU for Pridopidine in Huntington’s Disease

Retrieved on: 
Tuesday, March 12, 2024
Science, Neurology, Biotechnology, Research, Pharmaceutical, Health, Genetics, Clinical Trials, MAA, DSM-IV codes, ALS, Patient, Committee, EMA, ADM, VMAT2, European, Therapy, Cognition, FDA, CHMP, Neurodegenerative disease, Food, Pharmaceutical industry

“Pridopidine demonstrates consistent treatment benefits across independent measures that are important to patients and families.

Key Points: 
  • “Pridopidine demonstrates consistent treatment benefits across independent measures that are important to patients and families.
  • The benefits are clearly evident in those with HD who are not taking anti-dopaminergic medications (ADM),” said Dr. Michael R. Hayden, CEO of Prilenia.
  • “We appreciate the constructive discussions with European regulators regarding our data for pridopidine.
  • The Company will also consider global regulatory submissions for additional countries and regions following the regulatory review process in Europe.

European Commission Approves Pfizer’s PREVENAR 20® to Help Protect Infants and Children Against Pneumococcal Disease

Retrieved on: 
Wednesday, March 13, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Civil service commission, Streptococcus, Pneumonia, Inc., Public, Committee, PFE, European Medicines Agency, European, Safety, European Commission, Streptococcus pneumoniae, Vaccine, FDA, CHMP, Food

“The EC’s authorization of PREVENAR 20 for infants and children represents a significant opportunity to improve public health by helping to protect against the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer.

Key Points: 
  • “The EC’s authorization of PREVENAR 20 for infants and children represents a significant opportunity to improve public health by helping to protect against the 20 serotypes responsible for the majority of currently circulating pneumococcal disease in the EU,” said Alexandre de Germay, Chief International Commercial Officer, Executive Vice President, Pfizer.
  • The authorization is valid in all 27 EU member states plus Iceland, Lichtenstein and Norway.
  • Regulatory applications for PREVENAR 20 for the pediatric indication have been submitted to additional countries around the world.
  • These studies collectively enrolled more than 4,700 infants and 800 toddlers and children of all ages.

Astellas Receives Positive CHMP Opinion for XTANDI™ in Additional Recurrent Early Prostate Cancer Treatment Setting

Retrieved on: 
Friday, March 22, 2024
Civil service commission, Metastasis, American Urological Association, Prostate cancer, Astellas Pharma, Patient, BCR, Committee, EMA, Senior, European Medicines Agency, European, MPH, Safety, European Commission, FDA, CHMP, Food, Pharmaceutical industry

TOKYO, March 22, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy.1

Key Points: 
  • With approximately 9 out of 10 of these men developing metastatic disease, the need for new and effective treatment options is critical.
  • Today's positive opinion from the Committee is an important step forward for providing an additional treatment option for these patients and complements the existing efficacy and safety data supporting the use of XTANDI across the prostate cancer disease continuum.
  • Astellas is also discussing the EMBARK data with other regulatory authorities to support additional license applications for XTANDI in this indication in 2024 and beyond.
  • Astellas has already reflected the impact from this result in its financial forecast for the current fiscal year ending March 31, 2024.

U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma

Retrieved on: 
Friday, March 15, 2024
Dexamethasone, Type, Health, Survival, Multiple myeloma, Disease, Bortezomib, Oncology, Patient, Committee, EMA, Lenalidomide, European Medicines Agency, Daratumumab, DPD, Society, Johnson & Johnson, ODAC, Safety, ASCO, Food, Hematology, FDA, CHMP, Immunomodulatory imide drug, PVD, Annual general meeting, PDUFA, Pharmaceutical industry

RARITAN, N.J., March 15, 2024  /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. The committee reviewed survival and safety data from the Phase 3 CARTITUDE-4 study and voted unanimously in favor of CARVYKTI® (11 to 0) finding the risk-benefit assessment of CARVYKTI® for the proposed indication as favorable. A supplemental Biologics License Application (sBLA) supported by the CARTITUDE-4 study is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) date of April 5, 2024. 

Key Points: 
  • "We are pleased with the advisory committee's support for CARVYKTI in earlier lines of treatment based on the CARTITUDE-4 data," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • "As a physician and researcher committed to advancing patient care, the potential of CARVYKTI in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma."
  • The ODAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of oncologic diseases.
  • The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA.

Summary of opinion: Bimzelx, 21/03/2024 Positive

Retrieved on: 
Wednesday, April 3, 2024
Civil service commission, Psoriatic arthritis, Hidradenitis suppurativa, Methotrexate, Psoriasis, MRI, Magnetic resonance imaging, Inflammation, Committee, Nonsteroidal anti-inflammatory drug, Disease-modifying antirheumatic drug, HS, Medication package insert, C-reactive protein, Ankylosing spondylitis, European Commission, Marketing, CHMP, CRP, Axial spondyloarthritis

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Bimzelx.
  • The marketing authorisation holder for this medicinal product is UCB Pharma S.A.
  • The CHMP adopted a new indication for the treatment of hidradenitis suppurativa.
  • Ankylosing spondylitis (AS, radiographic axial spondyloarthritis)
    Bimzelx is indicated for the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy.

Summary of opinion: Nustendi, 21/03/2024 Positive

Retrieved on: 
Wednesday, April 3, 2024
Civil service commission, Hypercholesterolemia, Bempedoic acid, Patient, Tablet, Committee, Risk, Medication package insert, Diet, Ezetimibe, Moyamoya disease, European Commission, Cardiovascular disease, Marketing, CHMP, Pharmaceutical industry

On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Nustendi.

Key Points: 
  • On 21 March 2024, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Nustendi.
  • The marketing authorisation holder for this medicinal product is Daiichi Sankyo Europe GmbH.
  • For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
  • For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.