Two new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended two medicines for approval at its February 2020 meeting.
The Committee recommended granting a marketing authorisation for Fetcroja (cefiderocol) for the treatment of infections due to aerobic Gram-negative organisms in adults with limited treatment options.
The generic medicine Tigecycline Accord (tigecycline) received a positive opinion for the treatment of complicated skin and soft tissue (i.e. tissues just below the skin) infections and complicated intra-abdominal infections.
Three recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Alunbrig, Ofev and Otezla.
The CHMP also recommended the addition of a new pharmaceutical form for Entyvio: a 108 mg solution for injection to be given subcutaneously.
Negative opinion on extension of therapeutic indication
The CHMP adopted a negative opinion for an extension of indication for Emgality (galcanezumab) to add prevention of attacks in adults who suffer from episodic cluster headache.