From their meeting in November, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights. During the meeting, the CHMP announced the recommendations of four medicines for approval, including a medicine for use in countries outside the European Union (EU).
A positive opinion was adopted for Fexinidazole Winthrop (fexinidazole), which is the first oral-only medicine (tablet form) for the treatment of human African trypanosomiasis, also known as sleeping sickness due to Trypanosoma brucei gambiense. Under Article 58, which is a mechanism that allows CHMP to assess and share opinions on medicines for use outside the EU, this is the tenth medicine that has been recommended by the EMA.
The CHMP recommended extensions of therapeutic indication for Kisqali, Mabthera, Orkambi and Ravicti. The application to extend the use of Tecentriq (atezolizumab) to treat kidney cancer was withdrawn by the CHMP.
Following a review of disabling and potentially permanent side effects, the Committee has recommended suspending some quinolone and fluoroquinolone antibiotics, and are introducing changes including restrictions on the use of all others. The review took the views of patients, healthcare professionals and academics, who presented at EMA’s public hearing on these medicines in June 2018, into consideration.
For the meeting summary, and a full list of approvals, opinions and withdrawals, please click here.