The European Medicines Agency (EMA) took major strides in advancing healthcare during its Committee for Medicinal Products for Human Use (CHMP) meeting held from June 24 to 27, 2024. The committee issued positive opinions on ten groundbreaking medicines, several of which represent first-in-class therapies for life-threatening and chronic conditions. These recommendations, if ratified by the European Commission, are expected to reshape the landscape of treatment for conditions ranging from pulmonary hypertension to severe allergic reactions.
Among the most notable approvals was mResvia, the first mRNA vaccine targeting respiratory syncytial virus (RSV) in older adults. This marks only the second approved use of mRNA technology outside the COVID-19 context, potentially opening the door for a broader application of mRNA platforms in infectious disease prevention.
Another key development was the endorsement of Balversa (erdafitinib), aimed at treating adults with unresectable or metastatic urothelial carcinoma. This precision therapy targets FGFR genetic alterations and provides a crucial treatment option for patients with limited alternatives.
In a significant advancement for rare cardiovascular diseases, Winrevair (sotatercept) received approval under EMA’s PRIority MEdicines (PRIME) scheme for pulmonary arterial hypertension (PAH). The drug acts on the TGF-beta signaling pathway and is poised to offer new hope to patients suffering from this progressive and debilitating condition.
The CHMP also backed Eurneffy, the first needle-free nasal spray formulation of epinephrine, developed by ARS Pharmaceuticals. Designed to treat acute allergic reactions such as anaphylaxis, this innovation could improve compliance and usability for patients hesitant to use injectable devices.
Other approvals included:
- Ordspono, a treatment for lymphoma,
- Piasky, indicated for certain rare blood disorders,
- Tauvid, a diagnostic imaging agent for Alzheimer’s disease,
- And several biosimilars and generics that expand access to vital therapies across the EU.
While the approvals signaled progress, the CHMP also demonstrated its commitment to stringent evaluation by rejecting marketing authorization applications for two investigational drugs: one targeting amyotrophic lateral sclerosis (ALS) and another for macular degeneration. These decisions reflect the agency’s focus on ensuring only safe and effective treatments reach the European market.
The European Commission is expected to deliver final decisions on these recommendations in the coming months. If approved, these medicines will not only broaden therapeutic options but could also set new standards in areas such as mRNA vaccination, oncology precision medicine, and emergency allergy response across Europe.
