CHMP meeting highlights: January 2024

The European Medicine Agency’s human medicines committee (CHMP) recommended marketing authorisations for the regulatory approval of three medicines at its January 2024 meeting last week.

The CHMP recommended Exblifep (cefepime/enmetazobactam) as a treatment for complicated urinary tract infections, including pyelonephritis, hospital-acquired pneumonia, including ventilator associated pneumonia, and for treating bacteraemia caused by the aforementioned infections.

Ryzneuta (efbemalenograstim alfa) received a positive opinion from the CHMP as a medicine to reduce the duration of neutropenia and the incidence of febrile neutropenia due to chemotherapy.

Additionally, a positive opinion for Niapelf (paliperidone), a generic medicine for schizophrenia was adopted in the meeting.

Marketing authorisation refusals

Alongside these positive opinions, the CHMP also recommended the refusal of marketing authorisations for Nezglyal* (leriglitazone), as a treatment for cerebral adrenoleukodystrophy in males aged two years and over, as well as Syfovre (pegcetacoplan), to treat geographic atrophy secondary to age-related macular degeneration.

Medicine recommendations and indication extensions by the CHMP

Furthermore, the CHMP recommended the extension of indications for four medicines authorised in the EU: Abecma*, Aspaveli*, Prevenar 20 (previously Apexxnar), and Retsevmo.

In the meeting, the committee re-examined its earlier recommendation for Translarna (ataluren), a treatment intended for patients with Duchenne muscular dystrophy. The CHMP confirmed that it would not renew this conditional marketing authorisation.

Additional conclusions

In addition, the committee endorsed measures recommended by the EMA’s human medicines safety committee (PRAC). These were initially suggested to minimise the risks of the rare conditions posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine.

The CHMP confirmed that pseudoephedrine-containing medicines are authorised in various EU Member States alone, or in combination with medicines to treat symptoms of a cold and flu in individuals with nasal congestion. The committee also highlighted that pseudoephedrine is also authorised in some States to treat aerotitis in a fixed-dose combination with triprolidine.

As a result of these decisions, the European Commission will receive the CHMP’s opinion so that it can issue a legally binding decision across the EU. 

*During the development of this product, it was designated as an orphan medicine.

CHMP’s September 2023 meeting highlights