CHMP

Bristol Myers Squibb Receives Positive CHMP Opinion for Reblozyl® (luspatercept) for Treatment of Adults with Transfusion-Dependent Anemia due to Low- to Intermediate-Risk Myelodysplastic Syndromes (MDS)

Retrieved on: 
Friday, February 23, 2024
Oncology, Health, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, BMY, European Commission, EMA, Committee, Transfusion-dependent anemia, Bristol Myers Squibb, RBC, European, MDS, Civil service commission, CHMP, European Medicines Agency, Patient

The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

Key Points: 
  • The recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).
  • Upon approval, this would represent the fourth authorized indication for Reblozyl in the EU.
  • The CHMP adopted a positive opinion based on results from the pivotal Phase 3 COMMANDS trial.
  • Safety results were consistent with previous MDS studies and were in line with expected symptoms in this patient population.

European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Monday, February 19, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Janus, Ulcerative colitis, European Commission, EMA, Committee, Headache, Doctor of Philosophy, MD, FDA, European, Food, PFE, KU Leuven, Lymphocytopenia, Safety, Civil service commission, JAK, UC, CHMP, Patient, Proctitis, Inc., Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
  • “For the 2.6 million people in Europe living with UC, the unpredictable physical, mental, and emotional impacts of the condition can be debilitating.
  • This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023.
  • Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of VELSIPITY.

Summary of opinion: Xromi, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
Marketing, European Commission, Patient, Civil service commission, Committee, CHMP, Sickle cell disease, Medication package insert, Vaccine

On 22 February 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 Xromi.

Key Points: 
  • On 22 February 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 Xromi.
  • The marketing authorisation holder for this medicinal product is Nova Laboratories Ireland Limited.
  • The CHMP adopted an extension to the existing indication to include prevention of sickle cell disease complications in infants from 9 months of age.
  • 1New text in bold, removed text as strikethrough

Summary of opinion: Reblozyl, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
Marketing, Anemia, Luspatercept, European Commission, MDS, Civil service commission, Committee, CHMP, Medication package insert, Patient, EEIG

On 22 February 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 Reblozyl.

Key Points: 
  • On 22 February 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 Reblozyl.
  • The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.
  • For information, the full indications for Reblozyl will be as follows:
    Reblozyl is indicated in adults for the treatment of transfusion-dependent anaemia due to very low, low and intermediate-risk myelodysplastic syndromes (MDS) (see section 5.1).
  • Reblozyl is indicated in adults for the treatment of anaemia associated with transfusion dependent and non-transfusion dependent beta thalassaemia (see section 5.1).

Summary of opinion: Carvykti, 22/02/2024

Retrieved on: 
Sunday, March 10, 2024
Marketing, International, European Commission, Civil service commission, Committee, CHMP, Ciltacabtagene autoleucel, Medication package insert, Lenalidomide, Patient, Pharmaceutical industry

On 22 February 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 Carvykti.

Key Points: 
  • On 22 February 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 Carvykti.
  • The marketing authorisation holder for this medicinal product is Janssen-Cilag International NV.
  • The CHMP adopted an extension to the existing indication to include treatment of adult patients with relapsed and refractory multiple myeloma who have received at least one prior therapy.
  • 1New text in bold, removed as strikethrough

Summary of opinion: Cibinqo, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
Marketing, Atopic dermatitis, European Commission, Civil service commission, Committee, CHMP, Medication package insert, Ageing, Abrocitinib, Vaccine

On 22 February 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 Cibinqo.

Key Points: 
  • On 22 February 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 Cibinqo.
  • The marketing authorisation holder for this medicinal product is Pfizer Europe MA EEIG.
  • The CHMP adopted an extension to the existing indication to include treatment of adolescents aged 12 years and older.
  • For information, the full indication will therefore be as follows1:
    Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.

Summary of opinion: Kalydeco, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
European Commission, Committee, Medication package insert, Cystic fibrosis, Limited, Marketing, Civil service commission, Vertex Pharmaceuticals, CHMP, CFTR, Patient, Mutation, Ageing, Vaccine

On 22 February 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 Kalydeco.

Key Points: 
  • On 22 February 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 Kalydeco.
  • The marketing authorisation holder for this medicinal product is Vertex Pharmaceuticals (Ireland) Limited.
  • The CHMP recommended the approval of a new presentation of Kalydeco granules (13.4 mg granules in sachet) and an extension to the existing indication to allow use in children from 1 month of age.
  • For information, the indications for Kalydeco tablets remain unchanged and are provided in the summary of product characteristics (SmPC).

Summary of opinion: Keytruda, 22/02/2024 Positive

Retrieved on: 
Sunday, March 10, 2024
Carboplatin, GEJ, Hodgkin lymphoma, Patient, HNSCC, Cervical cancer, Ageing, CHL, Colorectal cancer, ALK, BTC, Head, Large intestine, Neck, Committee, Recurrence, IIC, Marketing, RCC, Renal cell carcinoma, Cancer, TPS, CHMP, Trastuzumab, TNBC, Paclitaxel, ASCT, Axitinib, Transitional epithelium, NSCLC, Lung cancer, European Commission, EGFR, Cholangiocarcinoma, Medication package insert, CRC, Neoplasm, Radiation, Cisplatin, Civil service commission, Pembrolizumab, Endometrial cancer, Nephrectomy, Platinum, MSI-H, Pemetrexed, Bevacizumab, Risk, Transitional cell carcinoma, CPS, PD-L1

Summary of opinion: Keytruda, 22/02/2024 Positive

Key Points: 


Summary of opinion: Keytruda, 22/02/2024 Positive

Questions and answers on the European Union framework for (traditional) herbal medicinal products, including those from a ‘non-European’ tradition

Retrieved on: 
Sunday, March 10, 2024
Well, DER, Fungus, Capsule, TUR, Interest, Animal, Part, Exercise, Database, Viral, Hepatitis, Powder, Collection, Directive, Union, Nutrient, DSM-IV codes, Volume, CTD, Legislation, Literature, Fermentation, Diabetes, Pharmacopoeia, Inhalation, Committee, Monograph, NTA, WEU, DCP, AIDS, See, Mineral, Marketing, Safety, Plant, MRA, Autoimmunity, Directive 2001/83/EC, GMP, Documentation, Seed, Heart failure, Distillation, CHMP, MRP, European Medicines Agency, Guideline, Disorder, Mutual, Convention, State, Tablet, Community, Clinical trial, Rapporteur, European Commission, Woman, Medication package insert, Vitamin, Quality, Authority, GACP, SAWP, Pharmacovigilance, Civil service commission, HMPS, Science, Health, Bibliography, Section 4, Infection, Kampo, Commission, Abbreviation, Pathology, Prescription, Human, Medication, Reproduction, EMA, NCA, Chapter One, EDQM, TAM, European Pharmacopoeia, European Economic Area, Food, Regulation (European Union), COM, TCM, Administration, Mutual recognition, Procedure, Medicine, Herbal, Answer, Q&A, HIV, EudraLex, Cancer, Public, Medicinal plants

1

Key Points: 
    • 1
      Committee on Herbal Medicinal Products (HMPC)

      Questions & Answers on the European Union framework
      for (traditional) herbal medicinal products, including those
      from a ?non-European? tradition

      Table of Content
      1.

    • European Pharmacopoeia

      SAWP

      Scientific Advice Working Party

      SmPC

      Summary of Product Characteristics

      THMP

      Traditional Herbal Medicinal Product

      TUR

      Traditional Use Registration

      WEU

      Well-Established Use

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Terminology of herbal medicinal products (Q&A 1-4)

      Question 1
      What are herbal substances, herbal preparations, and herbal medicinal products?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 4
      Are food supplements regulated under the European Union (EU) pharmaceutical legislation
      for (traditional) herbal medicinal products ((T)HMPs)?
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Regulation of herbal medicinal products in the European Union (Q&A 511)

      Question 5
      Where to find the pharmaceutical legislation and dossier requirements for herbal medicinal
      products (HMPs), including traditional herbal medicinal products (THMPs), in the European
      Union (EU)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • These countries have,
      through the EEA agreement, adopted the complete Union acquis on medicinal products and are
      consequently parties to the Union procedures.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Specific provisions for traditional herbal medicinal products (Q&A 1221)

      Question 12
      Which indications can be granted for traditional herbal medicinal products (THMPs)?

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Nov. 2023
      Answer 17

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.
    • Question 29
      Does the Committee on Herbal Medicinal Products (HMPC) hold a specific database on
      (registered) authorised (traditional) herbal medicinal products ((T)HMPs)?
    • Discussion with Member States intended to be

      Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

    • Questions & Answers on the European Union framework for (traditional) herbal
      medicinal products, including those from a ?non-European? tradition
      EMA/HMPC/402684/2013 Rev.

Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2024, European Medicines Agency, Amsterdam, the Netherlands, from 19 February 2024 to 22 February 2024

Retrieved on: 
Sunday, March 10, 2024
Committee, CHMP, Agency, Vaccine

Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2024

Key Points: 

Committee for Medicinal Products for Human Use (CHMP): 19-22 February 2024
The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines.
EventHumanMedicines