The European Medicines Agency (EMA) has approved Ryzneuta (efbemalenograstim alfa) for the treatment to shorten the duration of neutropenia and the frequency of febrile neutropenia in adults undergoing cancer chemotherapy.
Ryzneuta is a granulocyte colony-stimulating factor that acts by binding to specific cell surface receptors on hematopoietic cells, increasing the production and differentiation of mature and functionally active neutrophils from bone marrow precursor cells.
At its January meeting, the Committee for Medicinal Products for Human Use (CHMP) of the EMA approved the marketing authorization for Ryzneuta after finding that the drug shortened the duration of severe neutropenia during the first cycle of chemotherapy compared to placebo.
The most common side effects of the drug are musculoskeletal pain, such as bone and back pain, arthralgia, and pain in the extremities.
Ryzneuta will be available as a 20 mg injection solution.
Approval of Niapelf for Treatment of Schizophrenia
The EMA also approved marketing authorization for Niapelf (Paliperidone) for maintenance therapy of schizophrenia in adults stabilized on paliperidone or risperidone. Paliperidone acts by antagonistic activity on D2 and 5-HT2A receptors.
Niapelf, a psycholeptic antipsychotic, is a generic of Xeplion, which has been approved in the European Union (EU) since 2011. The CHMP stated that studies showed satisfactory bioequivalence.
Niapelf can be used without prior stabilization through oral treatment if the psychotic symptoms are mild to moderate and long-acting injectable therapy is needed, the committee said. The treatment must be initiated by doctors experienced in treating schizophrenia.
Denial of Approval for Nezglyal
The EMA recommended denying marketing authorization for Nezglyal, a drug for the treatment of cerebral adrenoleukodystrophy.
Cerebral adrenoleukodystrophy is caused by the accumulation of very long-chain fatty acids in the brain, causing inflammation and destruction of myelin, leading to impairment of signal transmission by nerve cells.
Nezglyal contains the active ingredient leriglitazone and was developed as a medicine for the treatment of adult males and children over 2 years of age.
When announcing its decision, the CHMP stated that there is no evidence that Nezglyal improved the walking ability of patients with cerebral adrenoleukodystrophy in 6 minutes compared to placebo. Concerns about weight gain and edema from taking the medication were also raised, and it was concluded that the benefits of Nezglyal do not outweigh the risks.
Rejection of Treatment for Age-Related Macular Degeneration
The EMA also rejected marketing authorization for Syfovre (Pegcetacoplan), a drug for the treatment of geographic atrophy caused by age-related macular degeneration.
When injected into the eyes of adult patients, it is intended to reduce the overactivity of the C3 protein of the complement system that leads to inflammation and cell death.
The committee concluded that while Syfovre slowed the growth of geographic atrophy lesions, it did not provide a clinically significant benefit to the patients.
Minimizing Risks of Pseudoephedrine-Containing Medications
The European Commission is being asked to decide on measures to minimize the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) in medications containing pseudoephedrine.
Pseudoephedrine-containing medications are used in EU countries to treat cold and flu symptoms such as headaches, fever, pain, or allergic rhinitis in people with stuffy noses.
PRES and RCVS are rare conditions that lead to reduced blood supply to the brain and can cause serious, life-threatening complications.
The CHMP announced on Friday that it supports the recommendations of the Pharmacovigilance Risk Assessment Committee (PRAC) of the EMA that medications 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. In addition, healthcare professionals should advise patients to discontinue the use of pseudoephedrine medications immediately and seek treatment if they experience symptoms of PRES or RCVS, such as sudden severe headaches, nausea, vomiting, confusion, seizures, and vision disturbances.
The recommendations followed a review of available evidence, including post-market safety data.
The European Commission will decide, based on the CHMP’s opinion, whether to issue a legally binding decision for all EU member countries.