Highlights of the Committee for Medicinal Products for Human Use (CHMP) meeting on 18-21 March 2024

12 new drugs recommended for approval

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval at its March 2024 meeting.

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

The commission adopted a positive opinion for assemble (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-negatives) that are resistant to many currently available antibiotics and where patients have have limited or sometimes no treatment options. Embleveo was assessed under the 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 hemoglobinuria, a rare genetic disorder and life-threatening blood disease that leads to the premature destruction of red blood cells by the immune system. This medicine was supported by the EMA’s Priority Medicines (PRIME) scheme, which provides enhanced and early regulatory and scientific support for promising medicines with the 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 that causes a gradual deterioration of vision 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 in advanced malignancies.

The CHMP recommended the granting of a marketing authorization for a agile* (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 body’s skeletal muscles are overstimulated and unable to relax- yes This can cause a very rapid rise in body temperature and/or a build-up of waste in the body (metabolic acidosis), which can prevent vital organs from working properly. A pediatric marketing authorization (PMA) was recommended. Neoatrichon (dopamine hydrochloride), for the treatment of hypotension in neonates, infants and children. Both drugs were submitted in hybrid applications, which are based partly on the results of preclinical tests and clinical trials of an already authorized reference product and partly on new data.

Three generic medicines also received a positive opinion from the committee: Dimethyl fumarate accord (dimethyl fumarate), Mylan dimethyl fumarate (dimethyl fumarate) i Neuraxpharm Dimethyl Fumarate (dimethyl fumarate). The three drugs are indicated for the treatment of adult and pediatric patients 13 years of age and older with relapsing-remitting multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering surrounding the nerves and own nerves

Recommendations on extensions of the therapeutic indication of six medicines

The committee recommended indication extensions for six medicines that are already authorized in the European Union (EU): Bimzelx, Nilemdo, I don’t understand, Onivyde liposomal pegylated*, Retsevmo i Xtandi.

Withdrawal of applications

Applications to extend the therapeutic indications of four medicines were withdrawn:

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

Question and answer documents regarding these withdrawals to expand therapeutic indications are available in the grid below.

Result of the arbitration proceedings

The CHMP completed a review of Micrazym, a pancreatic enzyme replacement therapy, following a disagreement between EU member states over its authorization through national procedures. The committee concluded that Micrazym’s benefits outweigh its risks and that marketing authorization should be granted in the Netherlands and EU Member States where the company has applied for marketing authorisation.

For more information, see the question and answer document in the grid below.

Reexamination of the referral procedure

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

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

Regulatory updates

The CHMP was updated on the outcome of the appeal judgment of the Court of Justice of 14 March 2024 in case C-291/22 P. The judgment examined issues related to the organization of scientific advisory groups (SAG) of the EMAs. The SAGs are groups of scientific experts who are called upon to answer specific questions raised by EMA committees during the evaluation of a medicine. In particular, the judgment has implications for the EMA’s policy on handling the conflicting interests of experts, in relation to SAG members. The EMA is currently in the process of carefully considering any necessary revisions to its policy in relation to SAGs. Any possible revisions to EMA policy will be communicated in due course.

Agenda and proceedings

The agenda for the March 2024 CHMP meeting is published on the EMA website. The 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 chart below.


*This product was designated as an orphan drug during development. Orphan designations are reviewed by the EMA’s Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available so far allows the medicinal product to maintain orphan status and be granted ten years of market exclusivity.

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