CHMP News - June 2014
30.06.2014
Six new medicines recommended for approval
The CHMP has recommended granting a marketing authorisation for six new medicines:
- Daklinza (daclatasvir) in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults,
- Abasria (insulin glargine) for the treatment of diabetes mellitus; Abasria is the first biosimilar insulin to be recommended for marketing authorisation in the European Union,
- Vizamyl (flutemetamol (18F)) for the visual detection of amyloid-beta neuritic plaques in the brain,
- Triumeq (abacavir sulfate/dolutegravir sodium/lamivudine), for the treatment of human immunodeficiency virus (HIV) infection in adults and adolescents from 12 years of age weighing at least 40 kg,
- Velphoro (mixture of polynuclear iron(iii)-oxyhydroxide, sucrose and starches) for the control of serum phosphorus levels in patients with end-stage renal disease,
- Clopidogrel/Acetylsalicylic acid Teva (clopidogrel / acetylsalicylic acid)for the prevention of atherothrombotic events.
Positive opinion on Vantobra adopted by written procedure
In addition to the positive opinions for the six new medicines adopted at the June 2014 meeting, the EMA would also like to highlight the CHMP’s recommendation to grant a marketing authorisation for the hybrid medicine Vantobra (tobramycin), adopted via written procedure on 2 June 2014.
Seven recommendations on extensions of therapeutic indications
The Committee recommended extensions of indications for Avastin, Eliquis, Enbrel, Eylea, Isentress, Kalydeco and Stivarga.
Re-examination of negative opinion on extension of indication for Avastin requested
The marketing-authorisation holder for Avastin has requested a re-examination of the CHMP’s negative opinion recommending the refusal of a change to the marketing authorisation for this medicine, adopted at its May 2014 meeting. The change concerned an extension of indication to add treatment of glioblastoma (an aggressive type of brain cancer). Upon receipt of the grounds of the request for re-examination, the CHMP will re-examine this opinion and issue a final opinion.
Withdrawals of applications
The applications for marketing authorisation for Faldaprevir Boehringer Ingelheim (faldaprevir), and for an extension of indication for Tasigna (nilotinib) have been withdrawn. For more information, please see question-and-answer documents in the grid below.
Agenda and minutes
The agenda and minutes of the June 2014 meeting are published on the EMA website.
Here you may find more information about the CHMP recommendations from the June 2014 meeting.
The Co-ordination Group for Mutual Recognition and Decentralised Procedure - Human (CMDh) recomendations from the June 2014 meeting will be available on the CMDh website, or here.
