Friday, April 26, 2013

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013

The Committee 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.

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