Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 April 2017

News 21/04/2017

Eleven medicines recommended for approval, including four orphans

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its April meeting.

The CHMP recommended granting marketing authorisations for two orphan medicines to treat rare neurodegenerative conditions in children: Spinraza (nusinersen) to treat patients with spinal muscular atrophy (SMA) and Brineura (cerliponase alfa) to treat neuronal ceroid lipofuscinosis type 2 (CLN2) disease. Both medicines were reviewed under EMA's accelerated assessment programme. For more information on these medicines, please see the press releases in the grid below.

Besponsa (inotuzumab ozogamicin) received a positive opinion from the Committee for the treatment of acute lymphoblastic leukaemia. Besponsa has an orphan designation.

The CHMP granted a positive opinion for Kevzara (sarilumab) for the treatment of rheumatoid arthritis.

Skilarence (dimethyl fumarate) received a positive opinion from the Committee for the treatment of psoriasis.

One hybrid application, Cuprior (trientine tetrahydrochloride), received a positive opinion for the treatment of Wilson's disease, a rare autosomal recessive inherited disorder. 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. Cuprior has an orphan designation.

Three biosimilar medicines were recommended for approval by the Committee: Erelzi (etanercept) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis; and Rixathon and Riximyo, both containing rituximab, for the treatment of non-Hodgkin's lymphoma, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis. Rixathon is also intended for the treatment of chronic lymphocytic leukaemia. A biosimilar medicine is a biological medicine that is highly similar to another biological medicine that is already authorised for use.

Two generic medicines received a positive opinion from the CHMP: Febuxostat Mylan (febuxostat) for the prevention and treatment of hyperuricaemia and Ucedane (carglumic acid) for the treatment of hyperammonaemia due to N-acetylglutamate synthase primary deficiency.

Three recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Avastin, Celsentri and Opdivo.

Withdrawal of application

An application for an initial marketing authorisation for Solithromycin Triskel EU Services (solithromycin) has been withdrawn. This medicine was intended for the treatment of community-acquired pneumonia, inhaled anthrax and inhaled tularaemia. A questions-and-answers document on this withdrawal is available in the grid below.

Agenda and minutes

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

CHMP statistics

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

More information on all other outcomes of the CHMP's April 2017 meeting is available in the grid below.

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Positive recommendations on new medicines

Name of medicineBesponsa
International non-proprietary name (INN)inotuzumab ozogamicin
Marketing-authorisation applicantPfizer Limited
Therapeutic indicationTreatment of acute lymphoblastic leukaemia
More information PDF iconSummary of opinion for Besponsa

Name of medicineBrineura
INNcerliponase alfa
Marketing-authorisation applicantBioMarin International Limited
Therapeutic indicationTreatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease
More information

PDF iconSummary of opinion for Brineura

Press release: New medicine for rare neurodegenerative disorder in children

Name of medicineCuprior
INNtrientine tetrahydrochloride
Marketing-authorisation applicantGMP-Orphan SA
Therapeutic indicationTreatment of Wilson's disease
More information PDF iconSummary of opinion for Cuprior

Name of medicineKevzara
INNsarilumab
Marketing-authorisation applicantSanofi-Aventis groupe
Therapeutic indicationTreatment of rheumatoid arthritis
More information PDF iconSummary of opinion for Kevzara

Name of medicineSkilarence
INNdimethyl fumarate
Marketing-authorisation applicantAlmirall S.A
Therapeutic indicationTreatment of psoriasis
More information PDF iconSummary of opinion for Skilarence

Name of medicineSpinraza
INNnusinersen
Marketing-authorisation applicantBiogen Idec Ltd
Therapeutic indicationTreatment of spinal muscular atrophy
More information

PDF iconSummary of opinion for Spinraza

Press release: First medicine for spinal muscular atrophy

Positive recommendation on new generic medicines

Name of medicineFebuxostat Mylan
INNfebuxostat
Marketing-authorisation applicantMYLAN S.A.S
Therapeutic indicationPrevention and treatment of hyperuricaemia
More information PDF iconSummary of opinion for Febuxostat Mylan

Name of medicineUcedane
INNcarglumic acid
Marketing-authorisation applicantLucane Pharma - Paris
Therapeutic indicationTreatment of hyperammonaemia due to N-acetylglutamate synthase primary deficiency
More information PDF iconSummary of opinion for Ucedane

Positive recommendations on new biosimilar medicines

Name of medicineErelzi
INNetanercept
Marketing-authorisation applicantSandoz GmbH
Therapeutic indicationTreatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis
More information PDF iconSummary of opinion for Erelzi

Name of medicineRixathon
INNrituximab
Marketing-authorisation applicantSandoz GmbH
Therapeutic indicationTreatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis
More information PDF iconSummary of opinion for Rixathon

Name of medicineRiximyo
INNrituximab
Marketing-authorisation applicantSandoz GmbH
Therapeutic indicationTreatment of non-Hodgkin's lymphoma, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis
More information PDF iconSummary of opinion for Riximyo

Positive recommendations on extensions of therapeutic indications

Name of medicineAvastin
INNbevacizumab
Marketing-authorisation holderRoche Registration Limited
More information PDF iconSummary of opinion for Avastin

Name of medicineCelsentri
INNmaraviroc
Marketing-authorisation holderViiV Healthcare UK Limited
More information PDF iconSummary of opinion for Celsentri

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More information PDF iconSummary of opinion for Opdivo

Outcomes of harmonisation procedures

Name of medicineEtopophos and associated names
INNetoposide
Marketing-authorisation holderBristol-Myers Squibb group of companies and associated companies
More informationQuestions and answers on Etopophos and associated names

Name of medicineVepesid and associated names
INNetoposide
Marketing-authorisation holderBristol-Myers Squibb group of companies and associated companies
More informationQuestions and answers on Vepesid and associated names

Withdrawal of application

Name of medicineSolithromycin Triskel EU Services
INNsolithromycin
More informationQuestions and answers on Solithromycin Triskel EU Services

Other updates

PDF iconRecommendations on eligibility to PRIME scheme
PDF iconOverview of (invented) names reviewed in March 2017 by the Name Review Group (NRG)
PDF iconScientific advice and protocol assistance
Start of Community reviews

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