Meeting highlights from the CHMP meeting in January 2017
Eight medicines recommended for approval, including two biosimilars
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January 2017 meeting.
The Committee recommended granting a marketing authorisation for Xeljanz (tofacitinib) for the treatment of rheumatoid arthritis.
One hybrid medicine, Jylamvo (methotrexate) received a positive opinion for the treatment of rheumatological disorders and psoriasis, and for the maintenance treatment of acute lymphoblastic leukaemia (ALL). Hybrid applications rely in part on the results of pre-clinical tests and clinical trials for a reference product and in part on new data.
Two biosimilar medicines were recommended for approval by the Committee: Amgevita and Solymbic, both containing adalimumab. Amgevita is for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn's disease, paediatric Crohn's disease, ulcerative colitis and uveitis. Solymbic is intended for the treatment of rheumatoid arthritis, enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. A biosimilar medicine is a biological medicine that is highly similar to another biological medicine that is already authorised for use.
The CHMP granted a positive opinion for Rolufta (umeclidinium) for the treatment of chronic obstructive pulmonary disease (COPD).
Also, the Committee granted a positive opinion for Tadalafil Lilly (tadalafil) for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.
Two generic medicines received a positive opinion from the Committee: Yargesa (miglustat) for the treatment of Gaucher disease and Daptomycin Hospira (daptomycin) for the treatment of complicated skin and soft-tissue infections (cSSTI), right-sided infective endocarditis (RIE) due to Staphylococcus aureus and S. aureus bacteraemia associated with right-sided infective endocarditis (RIE) or with cSSTI.
Two recommendations on extensions of therapeutic indications
The Committee recommended extensions of indications for Revlimid and Synjardy.
Withdrawals of applications
The application for a marketing authorisation for Zioxtenzo (pegfilgrastim) for treatment of neutropenia in cancer patients has been withdrawn. An application to extend the indication of Xgeva (denosumab) to treat hypercalcemia of malignancy (high levels of calcium in the blood caused by malignant disease) has also been withdrawn.
Outcome of review on medicines containing dienogest and ethinylestradiol for treatment of acne
The CHMP has recommended that medicines containing a combination of dienogest 2 mg and ethinylestradiol 0.03 mg can continue to be used to treat moderate acne when previous treatments applied to the skin or antibiotics taken by mouth have not worked. However, these medicines, which are also approved as hormonal contraceptives, should only be used in women who choose oral contraception.
There are no medicines in the Republic of Croatia containing dienogest and ethinylestradiol authorised for treatment of acne. Medicines containing dienogest and ethinylestradiol that are authorised in the Republic of Croatia have been authorised for oral contraception, therefore they have not been included in this procedure.
More information on this procedure is available on EMA's website.
More information on CHMP's January 2017 meeting is available on EMA's website.