From their meeting in March, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
At this meeting there were six recommendations for approvals of medicines, including one orphan medicine. The CHMP granted a conditional marketing authorisation for Rubraca (rucaparib), for the treatment of relapsed or progressive ovarian cancer. Rubraca was designated as an orphan medicine during its development.
Two biosimilar medicines were recommended for approval by the Committee and two generic medicines received a positive opinion from the CHMP. The CHMP adopted a negative opinion for Dexxience (betrixaban), which was expected to be used for the prevention of venous thromboembolism. A negative opinion was also adopted for Eladynos (abaloparatide) which was intended to be used to treat osteoporosis. There were also three recommendations on extensions of therapeutic indication.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.