From their meeting in October, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
The Committee has recommended seven medicines for approval, including the first Ebola vaccine, which would actively immunise adults at risk of infection with the virus. The vaccine was supported through EMA’s PRIority MEdicines (PRIME) scheme. The EMA’s Executive Director said “this is an important step towards relieving the burden of this deadly disease. The CHMP’s recommendation if the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola”.
They have recommended granting marketing authorisations (MA) for Baqsimi, the first non-injectable treatment for severe hypoglycaemia, and Rinvoq for rheumatoid arthritis. Quofenix for acute bacterial skin infections, Spravato for major depressive disorder, and the biosimilar medicine Pegfilgrastim Mundipharma all received positive opinions. The CHMP have also recommended a MA for Evenity, for which the Committee had previously adopted a negative opinion in June 2019. After re-consideration, a positive opinion has been granted for a restricted indication, pending further studies to follow its use in practice to ensure it is used correctly.
There were four recommendations on extensions of therapeutic indications; Darzalex, Kalydeco, Keytruda and Toujeo. There were also two negative opinions on extensions of therapeutic indication, and three withdrawals of applications for initial MAs.
The EMA also released an updated questions-and-answers document for marketing authorisation holders (MAH) who are reviewing their medicines for nitrosamine contamination. This document will support companies in review of their manufacturing practices.
For the meeting summary, and the full list of approvals, opinions and withdrawals, please click here.