The European Medicines Agency’s human medicines committee recommended six new medicines for approval at its October meeting, a round that extends well beyond the Foundayo oral GLP-1 opinion covered in today’s separate developing story.
Among the new medicines, Yuviwel (navepegritide) was recommended for achondroplasia in children, the inherited FGFR3 disorder that causes very short stature by affecting the growth of almost all bones in the body. Kizfizo (temozolomide) received a positive opinion for adults with glioblastoma multiforme and children with malignant glioma under a hybrid application that relies in part on data from an already authorised reference product. Rasonque for metastatic pancreatic cancer, the subject of a separate story here on October 15, completed the new drug list alongside Foundayo.
The committee also backed two biosimilars: Fovlussea (ranibizumab), covering wet age related macular degeneration, diabetic macular oedema and other retinal conditions, and Neuzafy (filgrastim) for neutropenia in adults and children. Five already authorised medicines, including Talvey, Tryngolza and Tukysa, were recommended for extensions of indication.
The meeting was not all approvals. The committee confirmed on re-examination its refusal of Yartemlea (narsoplimab) for transplant associated thrombotic microangiopathy, and two extension applications were withdrawn, Pfizer’s Ibrance in a breast cancer maintenance setting and AstraZeneca’s Truqap in metastatic prostate cancer. The committee also recommended making Nyxoid, a naloxone nasal spray for opioid overdose, available without a prescription.