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CHMP Recommends New Medicinal Products, Denies Approval for Two, and Expands Indications

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During its January 2024 session, the CHMP, a pivotal committee within the EMA, put forth recommendations for the approval of three innovative medicinal products, marking a significant advancement in healthcare treatment options.

The committee advocated for the approval of Exblifep (cefepime/enmetazobactam), a new antibiotic designed to address a spectrum of bacterial infections. Specifically, Exblifep targets complicated urinary tract infections, including pyelonephritis, and extends its efficacy to hospital-acquired pneumonia, and ventilator-associated pneumonia, as well as treating patients suffering from bacteremia that stems from the aforementioned infections. This recommendation reflects the committee’s commitment to combating resistant bacterial strains and enhancing patient care in critical conditions.

In the realm of oncology support, Ryzneuta (efbemalenograstim alfa) received the CHMP’s endorsement. This biologic agent is aimed at mitigating the effects of chemotherapy-induced neutropenia, a common yet serious side effect that reduces a patient’s immunity. By lessening the duration of neutropenia and decreasing the incidence of febrile neutropenia, Ryzneuta promises to improve the quality of life for patients undergoing chemotherapy, allowing for more aggressive treatment regimens with reduced risk of infection.

Further, the committee gave its positive opinion on Niapelf (paliperidone), proposing its generic version for the management of schizophrenia. This endorsement is particularly noteworthy as it signifies the CHMP’s support for accessible mental health treatments, providing a cost-effective option for patients suffering from this chronic and disabling brain disorder.

Adverse Recommendations for Two Medicinal Products

However, the CHMP’s rigorous evaluation process led to negative opinions for two medicinal products. Nezglyal* (leriglitazone), aimed at treating cerebral adrenoleukodystrophy in pediatric and adult male patients older than two years, was recommended for refusal. This decision underscores the challenges in addressing complex genetic disorders and highlights the committee’s stringent criteria for safety and efficacy.

Similarly, Syfovre (pegcetacoplan), intended for the treatment of geographic atrophy secondary to age-related macular degeneration, did not receive the committee’s approval. This decision reflects the ongoing struggle to find effective treatments for progressive retinal diseases that lead to vision loss, emphasizing the need for continued research and development.

Extensions of Therapeutic Indication for Four Authorized Medicinal Products

The CHMP also focused on expanding the therapeutic indications for four medicinal products already approved in the EU. This includes Abecma* and Aspaveli*, alongside Prevenar 20 (previously known as Apexxnar), and Retsevmo. These recommendations for extensions signify the committee’s dedication to maximizing the therapeutic potential of existing treatments across different patient populations and conditions.

Medicinal Products

Confirmation of Previous Decisions and Endorsement of Safety Measures

Following a thorough re-examination, the CHMP reaffirmed its earlier decision not to renew the conditional marketing authorization for Translarna (ataluren). This medication, aimed at treating Duchenne muscular dystrophy patients with a specific genetic defect, highlights the committee’s commitment to maintaining high standards for long-term efficacy and safety.

Moreover, the CHMP endorsed the PRAC’s recommendations to minimize the risks associated with pseudoephedrine-containing medications, which are used to treat cold and flu symptoms, nasal congestion, and aerotitis. This endorsement reflects the committee’s proactive approach to ensuring the safety of medicines that have widespread use in the EU.

Future Actions and Documentation

The opinions and recommendations issued by the CHMP will now proceed to the European Commission for a final decision, which will be legally binding across the EU member states. Additionally, a request for re-examination has been initiated by a consortium related to Synapse Labs Pvt. Ltd, concerning bioequivalent studies for generic medicines, indicating the dynamic and ongoing nature of medicinal product evaluation.

The CHMP’s commitment to transparency is evident in the publication of the meeting’s agenda and the forthcoming publication of detailed minutes on the EMA’s website, ensuring that stakeholders and the public are well-informed about its decisions and the rationale behind them.

 

Resource: European Medicines Agency, January 26, 2024

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