EMA is reflecting on medicines approved in 2023
In 2023, the agency put forward a total of 77 drugs for marketing authorization, which included 39 new APIs
The European Medicines Agency (EMA) released Human Medicines Highlights 2023 on Jan. 16, 2024, providing an overview of the medicines that received recommendations for marketing authorization in 2023. The agency provided recommendations for 77 medicines, with 39 of them being new active substances to the European Union. Two vaccines were suggested for safeguarding against respiratory syncytial virus (RSV). Furthermore, a cutting-edge medication utilizing CRISPR/Cas9 technology has been suggested as a potential treatment for two uncommon blood disorders.
Here are some recommended approvals for specific medications: - Omjjara (momelotinib), the first treatment for myelofibrosis - Columvi (glofitamab) and Tepkinly (epcoritamab) for the treatment of diffuse large B-cell lymphoma - Elrexfio (elranatamab) for the treatment of adult patients with relapsed or refractory multiple myeloma
Aqumeldi (enalapril maleate) is a medication that effectively treats heart failure in children up to 18 years of age.
Skyclarys (omaveloxolone) is a potential treatment option for individuals with Friedreich's ataxia.
Arexvy is designed to provide protection for adults aged 60 years and older against lower respiratory tract disease caused by RSV.
Seventeen orphan medicines were recommended for authorization, encompassing treatments for a range of conditions such as cancer, chronic hypoparathyroidism, sickle cell disease, Duchenne muscular dystrophy, and more.
The agency's Priority Medicines (PRIME) program has recommended three medicines: Elrexfio and Talvey for cancer treatments, and Casgevy for sickle cell disease treatment.
There were a total of 77 extensions for indications, with 38 drugs specifically approved for use in pediatrics.
In 2023, the agency did not approve three medicines: Albrioza for amyotrophic lateral sclerosis, Lagevrio for COVID-19 in adults, and Sohonos for fibrodysplasia ossificans progressive.
The agency oversees the monitoring of approved medications to ensure their quality and safety, while also offering industry guidance. Here are some tips and recommendations provided by the agency in 2023:
It has been advised to discontinue the use of Adakveo (crizanlizumab) for the prevention of painful crises in patients aged 16 years and older with sickle cell disease. This genetic condition causes the red blood cells to become rigid and sticky, transforming from a disc shape to a crescent shape resembling a sickle.
EMA issued a reminder to the industry about the importance of implementing measures to minimize the risks associated with the use of fluoroquinolone antibiotics.
Patients who are at a higher risk of blood clots, cardiovascular conditions, and cancer are advised to take a lower dose of Olumiant (baricitinib). This recommendation aligns with the dosing guidelines for other JAK inhibitors that are used to treat various chronic inflammatory disorders.
EMA has decided to suspend marketing authorization for over 350 generic drugs that were tested by Synapse Labs Pvt. Ltd., a contract research organization. This decision came after a thorough inspection of good clinical practice, which revealed that the supporting data were either lacking or insufficient to demonstrate bioequivalence.
Source: EMA
