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 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 medicinethat is highly similar to another biological medicine that is already authorised for use.

The CHMP granted positive opinions for two informed consent applications: Rolufta (umeclidinium) for the treatment of chronic obstructive pulmonary disease (COPD) and Tadalafil Lilly (tadalafil) for the treatment of erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia. An informed consent application makes use of data from the dossier of a previously authorised medicine, with themarketing authorisation holder of that medicine giving consent for the use of their data in the application.

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. aureusbacteraemia associated with 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) has been withdrawn. Zioxtenzo was developed as a biosimliar medicine to treat neutropenia in cancer patients.

An application to extend the indication of Xgeva (denosumab) to treat hypercalcemia of malignancy (high levels of calcium in the blood caused by cancer) has also been withdrawn.

Questions-and-answers documents on these withdrawals are available in the grid below.

Outcome of review on medicines containing dienogest and ethinylestradiol

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 suitable 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. For more information please see the public health communication in the grid below.

Posted on the EMA website on 27 January 2017