The European Medicines Agency (EMA) has approved Ryzneuta (efbemalenograstim alfa) as a treatment to reduce the duration of neutropenia and the incidence of febrile neutropenia in adults treated with cytotoxic chemotherapy for cancer.
Ryzneuta is a granulocyte colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors and increases the production and differentiation of mature and functionally active neutrophils from bone marrow precursor cells.
At its January meeting, the EMA's Committee for Medicinal Products for Human Use (CHMP) approved a marketing authorization after finding that the drug reduces the duration of severe neutropenia during the first cycle of chemotherapy compared with placebo.
The drug's most common side effects are musculoskeletal pain, such as bone and back pain, arthralgia, and pain in the extremities.
Ryzneuta will be available as a 20-mg solution for injection.
Approval of Niapelf for Schizophrenia Treatment
The EMA also approved a marketing authorization for Niapelf (paliperidone) for maintenance treatment of schizophrenia in adults stabilised with paliperidone or risperidone. Paliperidone works through antagonist activity at D2- and 5-HT2A receptors.
Niapelf, a psycholeptic antipsychotic, is a generic of Xeplion, which has been authorised in the European Union (EU) since 2011. The CHMP said that trials had demonstrated it had satisfactory bioequivalence.
Niapelf could be used without prior stabilisation with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable treatment is needed, the committee said. Treatment must be initiated by physicians experienced in the treatment of schizophrenia.
Authorization Refusal for Nezglyal
The EMA recommended refusing a marketing authorization for Nezglyal, a medicine intended for the treatment of cerebral adrenoleukodystrophy.
Cerebral adrenoleukodystrophy is caused by the accumulation of very long chain fatty acids in the brain that cause inflammation and destruction of myelin, resulting in impeded signalling by nerve cells.
Nezglyal contains the active substance leriglitazone and was developed as a medicine for treating male adults and children aged 2 years or older.
Announcing its decision, the CHMP said there was no evidence that Nezglyal improved how far patients with cerebral adrenoleukodystrophy could walk in 6 minutes compared with placebo. It also cited concerns about weight gain and oedema from taking the medication and concluded that the benefits of Nezglyal did not outweigh its risks.
Age-Related Macular Degeneration Treatment Turned Down
A refusal of a marketing authorization was also made by the EMA against Syfovre (pegcetacoplan), a medicine developed to treat geographic atrophy caused by age-related macular degeneration.
Injected into the eye of adult patients, it is intended to reduce overactivity by the C3 protein of the complement system that leads to inflammation and cell death.
The committee concluded that, although Syfovre slowed the growth of geographic atrophy lesions, it did not lead to clinically meaningful benefits for patients.
Minimizing Risk from Medicines Containing Pseudoephedrine
The European Commission will be asked to rule on measures to minimise the risks for posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine.
Pseudoephedrine-containing medicines are used in EU countries to treat cold and flu symptoms, such as headache, fever and pain, or allergic rhinitis in people with nasal congestion.
PRES and RCVS are rare conditions that can involve reduced blood supply to the brain and can cause serious, life-threatening complications.
The CHMP said on Friday that it endorsed recommendations made by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC) that medicines containing pseudoephedrine should not be used in patients with severe or uncontrolled hypertension or in patients with severe acute or chronic kidney disease or failure. Additionally, healthcare professionals should advise patients to stop using pseudoephedrine medicines immediately and seek treatment if they develop symptoms of PRES or RCVS, such as sudden onset severe headache, nausea, vomiting, confusion, seizures, and visual disturbances.
The recommendations followed a review of available evidence, including post-marketing safety data.
The European Commission will decide whether to issue a legally binding decision across EU member countries based on the CHMP opinion.