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.
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
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
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
Ongentys: Withdrawn application
Ontilyv
- INN
opicapone
- Marketing-authorisation holder
Bial Portela & Companhia S.A.
- More information
Ontilyv: Withdrawn application
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