PRAC April 2024 – PRAC finds no link between suicidal thoughts and thoughts of self-harm and GLP-1 receptor agonists and new safety information for HCPs on new Rybelsus tablets

During its April 2024 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has concluded that there is no available evidence supporting a link between GLP-1 receptor agonists and suicidal thoughts and thoughts of self-harm and advice to CHMP on new Rybelsus tablets.

Cibinqo

Active substance abrocitinib
Holder Pfizer NV/SA
Status Running
Indication the treatment of adolescents (12-17 years old) with severe atopic dermatitis or who have participated to the Abrocitinib Expanded access JADE REAL – B7451064 with EudraCT reference 2020-003610-12. 
Public documents

Shifting towards needs-driven healthcare: highlights from the Belgian high-level conference

On 17 and 18 April, the Federal Agency for Medicines and Health Products (FAMHP), the National Institute for Health and Disability Insurance (NIHDI) and the Health Care Knowledge Centre (KCE) organised a high-level conference on health-related needs as drivers for healthcare policy and innovation. This conference was organised in the context of the Belgian presidency of the Council of the EU. The aim is to establish a research and innovation ecosystem that focuses on the most pressing health needs.

Sotatercept

Active substance MK-7962
Holder Merck Sharp & Dohme LLC, A subsidiary of Merck & Co.

BALVERSA

Active substance erdafitinib
Holder Janssen-Cilag NV
Status Running
Indication This compassionate use program (CUP) is intended to provide early access to erdafitinib for the adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harboring susceptible FGFR3 genetic alterations with disease progression during or following at least one lin

Fintepla for DS

Active substance Fenfluramine (as fenfluramine hydrochloride)
Holder UCB PHARMA NV
Status Running
Indication Fintepla for the treatment of patients with Dravet syndrome who completed the open label study ZX008-1900 (EP0215; EudraCT number 2019-001331-31), or the open label study titled “Fenfluramine als anti-epilepticum bij Dravet syndroom en epileptische encephalopathieën

Fintepla for LGS

Active substance Fenfluramine (as fenfluramine hydrochloride)
Holder UCB PHARMA NV
Status Running
Indication Fintepla for the treatment of patients with Lennox-Gastaut syndrome who completed the open label study ZX008-1900 (EP0215, EudraCT number 2019-001331-31), or the open label study titled “Fenfluramine als anti-epilepticum bij Dravet syndroom en epileptische encephalo

Warning of counterfeit ivermectin tablets sold via social media

The FAMHP and Sciensano are warning about counterfeit ivermectin tablets that are being used for self-medication against COVID-19. Investigations show that these counterfeit ivermectin tablets are systematically underdosed or seriously contaminated with bacteria. In 2021, a total of 12 529 counterfeit ivermectin tablets originating from postal packages were seized. These tablets are regularly found in postal packages to this day.
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