EMA: oncology drugs again feature prominently in recommendations
Almost every third drug (32%) received a recommendation for approval from European Medicines Agency (EMA) have been associated with pathologies associated with oncological processes. This was announced by the European regulator, which on Tuesday published a full list of approvals that occurred over the past year.
In total, the European body gave the go-ahead to 77 new compounds, of which 25 are aimed at this type of pathology. “This is an area of enormous unmet medical need.“said EMA Medical Director Steffen Thierstrup speaking to the media, where he also emphasized the call to “promote treatments” hand in hand with the current European plan.
About the data offered by the EMA seven oncology drugs received conditional marketing authorization and one received accelerated marketing authorization.
Regarding the European cancer strategy, EMA’s scientific adviser Francesco Pignatti noted that “there are still many gaps that need to be filled” and among them he highlighted the collection of real-world evidence (RWE) to “address the complexity of drug development
Along with oncology approvals, the second section receiving the most recommendations is neurology and cardiovascular diseases. HeyIt also saw the approval of the first drug using CRISPR-Cas9 gene editing technology and two RSV vaccines.
Another section of the EMA was approval eight new biosimilars related to rare diseases such as cancer and multiple sclerosis. Currently, 97 biosimilars can be marketed in the European Union.
In the pediatric field, two new drugs have been approved to target heart failure and loss of hearing and balance in patients undergoing chemotherapy.