From their meeting in December, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
They have recommended five medicines for approval including two new medicines, one biosimilar and two generics.
The Committee recommended granting a marketing authorisation for Beovu (brolucizumab) for the treatment of neovascular age-related macular degeneration. Recarbrio (imipenem/cilastatin/relebactam) also received a positive opinion for the treatment of Gram-negative aerobic infections in adults with limited treatment options. A further positive opinion was recommended for Amsparity (adalimumab), a biosimilar medicine for inflammatory and autoimmune disorders. The generic medicines Azacitidine Accord and Dexmedetomidine Accord were also recommended for marketing authorisations.
There were eight recommendations for extensions of therapeutic indications, including Akynzeo, Cyramza, Darzalex, Dificlir, Erleada, Sirturo, Stelara and Vyndaqel.
There were no negative opinions or withdrawn applications in December. For the meeting summary, and a full list of approvals and opinions, click here.