Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024

-


New safety information for healthcare professionals

Veoza (fezolinetant): new recommendations to minimise risk of liver injury

The PRAC has agreed to a direct healthcare professional communication (DHPC) informing of the risk of drug-induced liver injury (DILI) with Veoza (fezolinetant) and has recommended monitoring of liver function before and during treatment.

Veoza is a medicine used to treat moderate-to-severe vasomotor symptoms (also referred to as hot flushes or night sweats) associated with menopause.

The committee considered a review of the potential risk of fezolinetant to cause drug-induced liver injury based on information from all available sources, including reports of suspected side effectsand studies published in the scientific literature.

Severe elevations of the liver enzymes alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (>10x upper limit of normal) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP) have been reported post marketing in women taking Veoza. In some cases, elevated liver function tests (LFTs) were associated with signs or symptoms suggestive of liver injury such as fatigue, pruritus, jaundice, dark urine, decreased appetite, or abdominal pain.

PRAC recommends LFTs must be performed before treatment is started. During the first three months of treatment, monthly LFTs must be carried out, and thereafter based on clinical judgement. During treatment, LFTs must be conducted if symptoms suggestive of liver injury occur. Monitoring of liver function should be maintained until they have normalised.

Treatment should be discontinued in certain cases of transaminase and bilirubin elevations or if liver enzyme elevations are accompanied by symptoms suggestive of liver injury.

The summary of product characteristics and package leaflet of Veoza are being updated to reflect the new risk information and recommendations.
Doxycycline: currently available evidence not supporting link with risk of suicidality

EMA’s safety committee (PRAC) has concluded that the currently available evidence is not sufficient to establish a causal relationship between the use of the antibiotic doxycycline and the risk of suicidality.

Doxycycline is a broad-spectrum antibiotic, widely used to treat a wide range of infections caused by bacteria such as acne, urinary and lower respiratory tract infections, dental infections, and skin infections. It is also used to prevent the development of certain infections, such as malaria.

A safety signal on the risk of suicidality, suicidal thoughts or actions with doxycycline was raised based on cases reported to the Finnish national competent authority, as well as further cases reported to EudraVigilance, the centralised European database of suspected side effects reports, and the medical literature.

The PRAC started its review in November 2023 and requested the marketing authorisation holders for doxycycline to perform a cumulative review of the data from all relevant sources.


Event : International Top Pharmaceutical Awards 


#Professor, #Lecturer, #Scientist, #Scholar, #Researcher, #Analyst, #Engineer, #Technician, #Coordinator, #Specialist, #Writer, #Assistant, #Associate, #Biologist, #Chemist, #Physicist, #Statistician, #DataScientist, #Consultant, #Coordinator, #ResearchScientist, #SeniorScientist, #JuniorScientist, #PostdoctoralResearcher, #LabTechnician, #ResearchCoordinator, #PrincipalInvestigator, #ClinicalResearchCoordinator, #



Get Connected Here 
--------------------------------- 
--------------------------------- 

Comments

Post a Comment

Popular posts from this blog

Sanofi’s Sarclisa wins in transplant-eligible multiple myeloma trial

-
Image
Sanofi’s Sarclisa (isatuximab) plus standard of care has been shown to extend the time that some multiple myeloma patients remain stable without disease progression. This was demonstrated in a Phase III trial (NCT03617731) with 662 newly diagnosed patients who were eligible for a stem cell transplant. The trial found that adding Sarclisa to the standard drugs – lenalidomide, bortezomib, and dexamethasone (Rvd) – resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared to RVd induction therapy. Sanofi said that these results reinforce the potential of Sarclisa as a backbone therapy when added to the current standard of care in various multiple myeloma patient populations. These recent findings build on data from 2021, where the trial met a different primary endpoint of minimal residual disease (MRD) negativity after induction therapy and before transplant. Around 50.1% of the newly diagnosed multiple myeloma patients achiev...
Read more

MDMA Papers Retracted for ‘Unethical Conduct’ on Heels of Lykos’ FDA Rejection

-
Image
A day after the regulator denied approval of Lykos’ MDMA-assisted PTSD therapy, a medical journal pulled three studies related to the use of the psychedelic in the indication. The medical journal Psychopharmacology on Saturday retracted three papers related to the use of the psychiatric substance MDMA for the treatment of post-traumatic stress disorder. The decision to pull the studies was driven by “protocol violations amounting to unethical conduct” at one of the study sites, according to the journal’s retraction note. The authors of the studies also confirmed to Psychopharmacology that they knew of these breaches when they submitted their manuscript “but did not disclose this information to the journal or remove data generated by this site from their analysis.” Many of the authors failed to fully disclose a “potential competing interest, ” according to the retraction notice, while some of the researchers were affiliated with either the Multidisciplinary Association for Psychedelic...
Read more

Cell and gene therapy companies must demonstrate strong value proposition for investment

-
Image
Investment for companies developing cell and gene therapies (CGTs) was discussed during the GenScript Biotech Global Forum London 2024 conference held on 20 November 2024. Following a sharp drop in CGT investment in 2022, trends suggest that CGT investment is currently undergoing a “renormalisation”. However, investors continue to be selective, said speakers Josh Resnik, senior managing director at RA Capital Management, and Ping Shek, managing director at Stifel’s Healthcare Investment Banking Division. CGTs have faced challenges attracting investment due to the large amount of capital required to manufacture CGTs, as well as hurdles relating to reimbursement of one-off, high-cost therapies and patient access. Resnik noted that investor sentiment about CGTs was impacted by competitive pressures from “not-so-complicated biologics” such as antibody-drug conjugates, radiopharmaceuticals, and T-cell engagers in oncology and immunology. Resnik noted that CGTs must demonstrate a stron...
Read more