Seven new medicines recommended for approval


  • The Committee recommended the approval of the first combined tissue-engineered medicine to be authorised across the European Union (EU). MACI (matrix-induced autologous chondrocyte implantation) is an advanced-therapy medicinal product (ATMP) intended for the repair of cartilage defects.
  • The Committee also gave a positive recommendation for the approval of Nuedexta, the first medicine for pseudobulbar effect approved in the EU.
  • Four medicines to treat cancer received a positive opinion by the Committee:  Erivedge, for the treatment of advanced basal cell carcinoma; Xtandi, for the treatment of prostate cancer and the two generic medicines Capecitabine Sun and Imatinib Accord.
  • The CHMP also recommended that Spedra should be granted a marketing authorisation for the treatment of erectile dysfunction.


Negative opinion for Xeljanz


  • The Committee adopted a negative opinion for Xeljanz for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis.


Two recommendations for extensions of indication


  • The CHMP recommended an extension of the existing indication for Revlimid and also for RoActemra.


CHMP confirms recommendation to restrict use of Protelos/Osseor


  • The Committee has recommended a restriction in the use of the osteoporosis medicine Protelos/Osseor, following an assessment of data showing an increased risk of serious heart problems.


Update on shortages


  • The shortage of Caelyx, a medicine for the treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi’s sarcoma, has been resolved. 
  • A shortage of Increlex has been reported. This is a medicine used for the treatment of patients aged two to 18 years who are short for their age due to a condition known as ‘severe primary insulin-like-growth-factor-1 deficiency’; information on how to deal with the shortage will be sent to healthcare professionals in a direct healthcare professional communication (DHPC).


Posted on the EMA website on 26 April 2013