Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 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 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 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 the marketing 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. aureus bacteraemia 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 biosimilar 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.

Agenda and minutes

The agenda of the January 2017 meeting is published on EMA's website. Minutes of the December 2016 CHMP meeting will be published next week.

CHMP statistics

Key figures from the January 2017 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP's January 2017 meeting, is available in the grid below.

Download image in pdf format

Positive recommendation on new medicine

Name of medicine	Xeljanz
INN	tofacitinib
Marketing-authorisation applicant	Pfizer Limited
Therapeutic indication	Treatment of rheumatoid arthritis
More information	Summary of opinion for Xeljanz

Positive recommendations on new informed-consent applications

Name of medicine	Rolufta
INN	umeclidinium
Marketing-authorisation applicant	GlaxoSmithKline Trading Services
Therapeutic indication	Treatment of chronic obstructive pulmonary disease (COPD)
More information	Summary of opinion for Rolufta

Name of medicine	Tadalafil Lilly
INN	tadalafil
Marketing-authorisation applicant	Eli Lilly Nederland B.V.
Therapeutic indication	Treatment of erectile dysfunction in adult males and treatment of the signs and symptoms of benign prostatic hyperplasia
More information	Summary of opinion for Tadalafil Lilly

Positive recommendations on new generic medicines

Name of medicine	Daptomycin Hospira
INN	daptomycin
Marketing-authorisation applicant	Hospira UK Limited
Therapeutic indication	Treatment of complicated skin and soft tissue infections (cSSTI), right-sided infective endocarditis (RIE) due to Staphylococcus aureus and S. aureus bacteraemia associated with RIE or with cSSTI
More information	Summary of opinion for Daptomycin Hospira

Name of medicine	Yargesa
INN	miglustat
Marketing-authorisation applicant	JensonR+ Limited
Therapeutic indication	Treatment of Gaucher disease
More information	Summary of opinion for Yargesa

Positive recommendation on new hybrid medicine

Name of medicine	Jylamvo
INN	methotrexate
Marketing-authorisation applicant	Therakind Limited
Therapeutic indication	Treatment of rheumatological disorders and psoriasis and for the maintenance treatment of acute lymphoblastic leukaemia (ALL)
More information	Summary of opinion for Jylamvo

Positive recommendations on new biosimilar medicines

Name of medicine	Amgevita
INN	adalimumab
Marketing-authorisation applicant	Amgen Europe B.V.
Therapeutic indication	Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis
More information	Summary of opinion for Amgevita

Positive recommendations on extensions of therapeutic indications

Name of medicine	Revlimid
INN	lenalidomide
Marketing-authorisation holder	Celgene Europe Limited
More information	Summary of opinion for Revlimid

Name of medicine	Synjardy
INN	empagliflozin / metformin
Marketing-authorisation holder	Boehringer Ingelheim GmbH
More information	Summary of opinion for Synjardy

Withdrawals of applications

Name of medicine	Xgeva
INN	denosumab
Marketing-authorisation holder	Amgen Europe B.V.
More information	Questions and answers on Xgeva

Name of medicine	Zioxtenzo
INN	pegfilgrastim
Marketing-authorisation holder	Sandoz GmbH
More information	Questions and answers on Zioxtenzo

Public health recommendation

Name of medicine	Dienogest / Ethinylestradiol
INN	dienogest / ethinylestradiol
More information	Dienogest/ethinylestradiol can be used for acne after certain other treatments have failed

Other updates

Start of Community reviews

Recommendations on eligibility to PRIME scheme

Scientific advice and protocol assistance