EMA: Quick review for four meds
A few months ago, the EMA introduced its new accelerated access scheme, PRIME. Now, the agency has published the first few therapies that will use the chance to speed their breakthrough meds through the approval process.
The FDA has had a Breakthrough Therapy designation in place since 2012, which allowed a quicker route for gamechanging therapies through the US agency’s approval process. In March, the EMA launched a similar programme, called the Priority Medicines (PRIME) scheme.
Now, the agency has named the first four therapies that will run in PRIME. EMA announced that most applications, 14 out of 18, were rejected. Only one European company has made the cut: Swiss Novimmune has entered PRIME with NI-0501, an interferon gamma inhibitor mAb for the treatment of inflammation that also has a Breakthrough nomination in the US. The antibody has received orphan drug designation in both the EU and the US and is currently recruiting for Phase II.
Three more products hail from the US: Biogen’s Alzheimer’s drug Aducanumab, Chemocentryx’ autoimmune disease small molecule drug CCX168 and Kite Pharma’s cancer treatment KTE-C19.
EMA said that it has received annother fourteen applications, which will now be reviewed in due course.
© european-biotechnology-news.com/um
NOD-Proteindesign.Andreas Heddergott/TUM.jpg
Certest
Consilium