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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2024

EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.
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12 new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its March 2024 meeting.

The CHMP recommended granting a marketing authorisation for Awiqli (insulin icodec) for the treatment of diabetes mellitus in adults.

The committee adopted a positive opinion for Emblaveo (aztreonam-avibactam), an antibiotic indicated for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia and infections caused by certain types of bacteria (aerobic Gram-negative) that are resistant to many currently available antibiotics and where patients have limited or sometimes no treatment options. Emblaveo was evaluated under EMA's accelerated assessment mechanism because it is considered to address an unmet medical need. See more details in the news announcement in the grid below.

The CHMP gave a positive opinion for Fabhalta* (iptacopan), an oral treatment for adults with paroxysmal nocturnal haemoglobinuria, a rare genetic disorder and potentially life-threatening blood disease leading to the premature destruction of red blood cells by the immune system. This medicine was supported through EMA’s Priority Medicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs. See more details in the news announcement in the grid below.

Lytenava (bevacizumab) received a positive opinion from the CHMP for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease causing gradual vision impairment mainly in the elderly.

The committee adopted positive opinions for three biosimilar medicines:

  • Jubbonti (denosumab), for the treatment of osteoporosis and bone loss.
  • Omlyclo (omalizumab), for the treatment of asthma, severe chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria.
  • Wyost (denosumab), for the prevention of skeletal related events with advanced malignancies.

The CHMP recommended granting a marketing authorisation for Agilus* (dantrolene sodium, hemiheptahydrate), indicated in adults and children of all ages for the treatment of malignant hyperthermia, a life threatening emergency condition in which the skeletal muscles of the body are over-stimulated and are unable to relax. This can cause a very fast increase of body temperature and/or a build-up of waste products in the body (metabolic acidosis), which can stop vital organs from working properly. A paediatric-use marketing authorisation (PUMA) was recommended for Neoatricon (dopamine hydrochloride), for the treatment of hypotension in neonates, infants and children. Both medicines were submitted in hybrid applications, which rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

Three generic medicines also received a positive opinion from the committee: Dimethyl fumarate Accord (dimethyl fumarate), Dimethyl fumarate Mylan (dimethyl fumarate) and Dimethyl fumarate Neuraxpharm (dimethyl fumarate). All three medicines are indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and the nerves themselves.

Recommendations on extensions of therapeutic indication for six medicines

The committee recommended extensions of indication for six medicines that are already authorised in the European Union (EU): Bimzelx, Nilemdo, Nustendi, Onivyde pegylated liposomal*, Retsevmo and Xtandi.

Withdrawals of applications

The applications to extend the therapeutic indications of four medicines were withdrawn:

  • Adcetris, to extend the use to adults with CD30-positive, not otherwise specified peripheral T-cell lymphoma, a cancer of T cells (a type of white blood cells called lymphocytes that are part of the immune system), when the cancer has not been treated before;
  • Ongentys and Ontilyv, to extend their use to treat signs and symptoms of Parkinson’s disease;
  • Orencia, for the prevention of acute graft-versus-host disease in adults and children from two years of age with cancers that affect blood cells.

Question-and-answer documents on these withdrawals to extend therapeutic indications are available in the grid below.

Outcome of arbitration procedures

The CHMP completed a review of Micrazym, a pancreatic enzyme replacement therapy, following a disagreement among EU Member States regarding its authorisation via national procedures. The committee concluded that the benefits of Micrazym outweigh its risks, and the marketing authorisation should be granted in the Netherlands and in the Member States of the EU where the company has applied for a marketing authorisation.

For more information, see the Q&A document in the grid below.

Re-examination of referral procedure

The CHMP confirmed its recommendation to suspend or not grant the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd, a contract research organisation located in Pune, India. This confirmation concludes the re-examination requested by the applicants and marketing authorisation holders for some of the medicines concerned.

For more information, see public health communication in the grid below.

Regulatory updates

The CHMP was updated on the outcome of the appellate judgment of the Court of Justice of 14 March 2024 in Case C-291/22 P. The judgment examined questions related to the organisation of EMA’s Scientific Advisory Groups (SAGs). SAGs are groups of scientific experts that are called upon to respond to specific questions posed by EMA’s committees during the evaluation of a medicine. In particular, the judgment has implications on EMA’s policy on the handling of competing interests of experts, in relation to SAG members. EMA is currently in the process of carefully considering any needed revisions of its policy in relation to SAGs. Any possible revisions of EMA’s policy will be communicated in due time.

Agenda and minutes

The agenda of the March 2024 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.

CHMP statistics

Key figures from the March 2024 CHMP meeting are represented in the graphic below.


*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine’s orphan status and granting the medicine ten years of market exclusivity.

CHMP figures from March 2024

Positive recommendations on new medicines

Awiqli

International non-proprietary name (INN)

insulin icodec

Marketing-authorisation applicant

Novo Nordisk A/S

Therapeutic indication

Treatment of diabetes mellitus in adults.

More information

Emblaveo

INN

aztreonam / avibactam

Marketing-authorisation applicant

Pfizer Europe Ma EEIG

Therapeutic indication

Treatment of complicated Intra-Abdominal Infection (cIAI), complicated Urinary Tract Infection (cUTI), including pyelonephritis, Hospital-acquired pneumonia (HAP), including ventilator associated pneumonia (VAP), and aerobic Gram-negative infections with limited treatment options.

More information
News

Fabhalta

INN

iptacopan

Marketing-authorisation applicant

Novartis Europharm Limited

Therapeutic indication

Treatment of paroxysmal nocturnal haemoglobinuria.

More information
News

Lytenava

INN

bevacizumab 

Marketing-authorisation applicant

Outlook Therapeutics Limited

Therapeutic indication

Treatment of neovascular (wet) age-related macular degeneration (nAMD).

More information

Positive recommendation on new biosimilar medicines

Jubbonti

INN

denosumab

Marketing-authorisation applicant

Sandoz GmbH

Therapeutic indication

Treatment of osteoporosis.

More information

Omlyclo

INN

omalizumab

Marketing-authorisation applicant

Celltrion Healthcare Hungary Kft.

Therapeutic indication

Treatment of asthma.

More information

Wyost

INN

denosumab

Marketing-authorisation applicant

Sandoz GmbH

Therapeutic indication

Prevention of skeletal related events with advanced malignancies.

More information

Positive recommendations on new hybrid medicines

Agilus

INN

dantrolene sodium, hemiheptahydrate

Marketing-authorisation applicant

Norgine B.V.

Therapeutic indication

In combination with adequate support measures, Agilus is indicated for the treatment of malignant hyperthermia in adults and children of all ages.

More information

Neoatricon

INN

dopamine hydrochloride

Marketing-authorisation applicant

BrePco Biopharma Limited

Therapeutic indication

Treatment of hypotension in neonates, infants and children.

More information

Positive recommendations on new generic medicines

Dimethyl fumarate Accord

INN

dimethyl fumarate

Marketing-authorisation applicant

Accord Healthcare

Therapeutic indication

For the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

More information

Dimethyl fumarate Mylan

INN

dimethyl fumarate

Marketing-authorisation applicant

Mylan Ireland Limited

Therapeutic indication

For the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

More information

Dimethyl fumarate Neuraxpharm

INN

dimethyl fumarate

Marketing-authorisation applicant

Neuraxpharm Pharmaceuticals S.L.

Therapeutic indication

For the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS).

More information

Positive recommendations on extensions of indications

Bimzelx

INN

bimekizumab

Marketing-authorisation holder

UCB Pharma S.A

More information

Nilemdo

INN

bempedoic acid 

Marketing-authorisation holder

Daiichi Sankyo Europe GmbH

More information

Nustendi

INN

bempedoic acid / ezetimibe 

Marketing-authorisation holder

Daiichi Sankyo Europe GmbH

More information

Onivyde pegylated liposomal

INN

irinotecan hydrochloride trihydrate

Marketing-authorisation holder

Les Laboratoires Servier

More information

Retsevmo

INN

selpercatinib

Marketing-authorisation holder

Eli Lilly Nederland B.V.

More information

Xtandi

INN

enzalutamide

Marketing-authorisation holder

Astellas Pharma Europe B.V.

More information

Withdrawal of applications to change the marketing authorisation

Adcetris

INN

brentuximab vedotin

Marketing-authorisation holder

Takeda Pharma A/S

More information

Ongentys

INN

opicapone

Marketing-authorisation holder

Bial Portela & Companhia S.A.

More information

Ontilyv

INN

opicapone

Marketing-authorisation holder

Bial Portela & Companhia S.A.

More information

Orencia

INN

abatacept

Marketing-authorisation holder

Bristol-Myers Squibb Pharma

More information

Outcome of arbitration procedures

Micrazym

INN

porcine pancreas enzymes

Marketing-authorisation applican

Avva Pharmaceuticals Ltd.

More information

Re-examinations of referral procedure

Synapse Labs Pvt. Ltd.

More information

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