Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2017

News 27/01/2017

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 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.

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.

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Positive recommendation on new medicine

Name of medicineXeljanz
INNtofacitinib
Marketing-authorisation applicantPfizer Limited
Therapeutic indicationTreatment of rheumatoid arthritis
More information PDF iconSummary of opinion for Xeljanz

Positive recommendations on new informed-consent applications

Name of medicineRolufta
INNumeclidinium
Marketing-authorisation applicantGlaxoSmithKline Trading Services
Therapeutic indicationTreatment of chronic obstructive pulmonary disease (COPD)
More information PDF iconSummary of opinion for Rolufta

Name of medicineTadalafil Lilly
INNtadalafil
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of erectile dysfunction in adult males and treatment of the signs and symptoms of benign prostatic hyperplasia
More information PDF iconSummary of opinion for Tadalafil Lilly

Positive recommendations on new generic medicines

Name of medicineDaptomycin Hospira
INNdaptomycin
Marketing-authorisation applicantHospira UK Limited
Therapeutic indicationTreatment 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 PDF iconSummary of opinion for Daptomycin Hospira

Name of medicineYargesa
INNmiglustat
Marketing-authorisation applicantJensonR+ Limited
Therapeutic indicationTreatment of Gaucher disease
More information PDF iconSummary of opinion for Yargesa

Positive recommendation on new hybrid medicine

Name of medicineJylamvo
INNmethotrexate
Marketing-authorisation applicantTherakind Limited
Therapeutic indicationTreatment of rheumatological disorders and psoriasis and for the maintenance treatment of acute lymphoblastic leukaemia (ALL)
More information PDF iconSummary of opinion for Jylamvo

Positive recommendations on new biosimilar medicines

Name of medicineAmgevita
INNadalimumab
Marketing-authorisation applicantAmgen Europe B.V.
Therapeutic indicationTreatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis
More information PDF iconSummary of opinion for Amgevita

Name of medicineSolymbic
INNadalimumab
Marketing-authorisation applicantAmgen Europe B.V.
Therapeutic indicationTreatment of rheumatoid arthritis, enthesitis-related arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis
More information PDF iconSummary of opinion for Solymbic

Positive recommendations on extensions of therapeutic indications

Name of medicineRevlimid
INNlenalidomide
Marketing-authorisation holderCelgene Europe Limited
More information PDF iconSummary of opinion for Revlimid

Name of medicineSynjardy
INNempagliflozin / metformin
Marketing-authorisation holderBoehringer Ingelheim GmbH
More information PDF iconSummary of opinion for Synjardy

Withdrawals of applications

Name of medicineXgeva
INNdenosumab
Marketing-authorisation holderAmgen Europe B.V.
More information PDF iconQuestions and answers on Xgeva

Name of medicineZioxtenzo
INNpegfilgrastim
Marketing-authorisation holderSandoz GmbH
More information PDF iconQuestions and answers on Zioxtenzo

Public health recommendation

Name of medicineDienogest / Ethinylestradiol
INNdienogest / ethinylestradiol
More information PDF iconDienogest/ethinylestradiol can be used for acne after certain other treatments have failed

Other updates

PDF iconStart of Community reviews
PDF iconRecommendations on eligibility to PRIME scheme
PDF iconScientific advice and protocol assistance

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