EMA’s human medicines committee (CHMP) recommended four medicines for approval, including a medicine for use in countries outside the European Union, at its November 2018 meeting.
The CHMP adopted a positive opinion for Fexinidazole Winthrop (fexinidazole), the first oral-only medicine (tablets) for the treatment of human African trypanosomiasis, commonly known as sleeping sickness, due to Trypanosoma brucei gambiense. This is the tenth medicine recommended by EMA under Article 58, a mechanism that allows the CHMP to assess and give opinions on medicines for use outside the European Union.
Erleada (apalutamide) received a positive opinion for the treatment of non-metastatic castration resistant prostate cancer.
The CHMP recommended granting a marketing authorisation for Macimorelin Aeterna Zentaris (macimorelin), for the diagnosis of growth hormone deficiency in adults.
The generic medicine Silodosin Recordati (silodosin) received a positive opinion from the CHMP for the treatment of the signs and symptoms of benign prostatic hyperplasia.
Four recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Kisqali, Mabthera, Orkambi and Ravicti.
Positive recommendations on extension of therapeutic indication following re-examination
The Committee recommended an extension of therapeutic indication for Blincyto (blinatumomab) in patients with residual cancer cells in the body after previous treatment, after re-examining its negative opinion for this medicine adopted in July 2018.
The CHMP also adopted a positive opinion for the use of Opdivo (nivolumab) and Yervoy (ipilimumab) in combination to treat renal cell carcinoma (kidney cancer), after re-examining its negative opinion adopted in July 2018.
Outcome of review on quinolone and fluoroquinolone antibiotics
The CHMP recommended suspending some quinolone and fluoroquinolone antibiotics and introducing changes including restrictions on the use of all others following a review of disabling and potentially permanent side effects reported with these medicines. The review incorporated the views of patients, healthcare professionals and academics presented at EMA’s public hearing on these medicines in June 2018.
Withdrawal of extension of indication application
The application to extend the use of Tecentriq (atezolizumab) to treat kidney cancer was withdrawn.