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

21 April 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.

 

CHMP statistics: April 2017

Positive recommendations on new medicines

Name of medicine	Besponsa
International non-proprietary name (INN)	inotuzumab ozogamicin
Marketing-authorisation applicant	Pfizer Limited
Therapeutic indication	Treatment of acute lymphoblastic leukaemia
More information	CHMP summary of positive opinion for Besponsa

 

Name of medicine	Brineura
INN	cerliponase alfa
Marketing-authorisation applicant	BioMarin International Limited
Therapeutic indication	Treatment of neuronal ceroid lipofuscinosis type 2 (CLN2) disease
More information	CHMP summary of positive opinion for Brineura   Press release: New medicine for rare neurodegenerative disorder in children

 

Name of medicine	Cuprior
INN	trientine tetrahydrochloride
Marketing-authorisation applicant	GMP-Orphan SA
Therapeutic indication	Treatment of Wilson's disease
More information	CHMP summary of positive opinion for Cuprior

 

Name of medicine	Kevzara
INN	sarilumab
Marketing-authorisation applicant	Sanofi-Aventis groupe
Therapeutic indication	Treatment of rheumatoid arthritis
More information	CHMP summary of positive opinion for Kevzara

 

Name of medicine	Skilarence
INN	dimethyl fumarate
Marketing-authorisation applicant	Almirall S.A
Therapeutic indication	Treatment of psoriasis
More information	CHMP summary of positive opinion for Skilarence

 

Name of medicine	Spinraza
INN	nusinersen
Marketing-authorisation applicant	Biogen Idec Ltd
Therapeutic indication	Treatment of spinal muscular atrophy
More information	CHMP summary of positive opinion for Spinraza   Press release: First medicine for spinal muscular atrophy

 

Positive recommendation on new generic medicines

Name of medicine	Febuxostat Mylan
INN	febuxostat
Marketing-authorisation applicant	MYLAN S.A.S
Therapeutic indication	Prevention and treatment of hyperuricaemia
More information	CHMP summary of positive opinion for Febuxostat Mylan

 

Name of medicine	Ucedane
INN	carglumic acid
Marketing-authorisation applicant	Lucane Pharma - Paris
Therapeutic indication	Treatment of hyperammonaemia due to N-acetylglutamate synthase primary deficiency
More information	CHMP summary of positive opinion for Ucedane

 

Positive recommendations on new biosimilar medicines

Name of medicine	Erelzi
INN	etanercept
Marketing-authorisation applicant	Sandoz GmbH
Therapeutic indication	Treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis, plaque psoriasis and paediatric plaque psoriasis
More information	CHMP summary of positive opinion for Erelzi

 

Name of medicine	Rixathon
INN	rituximab
Marketing-authorisation applicant	Sandoz GmbH
Therapeutic indication	Treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis
More information	CHMP summary of positive opinion for Rixathon

 

Name of medicine	Riximyo
INN	rituximab
Marketing-authorisation applicant	Sandoz GmbH
Therapeutic indication	Treatment of non-Hodgkin's lymphoma, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis
More information	CHMP summary of positive opinion for Riximyo

 

Positive recommendations on extensions of therapeutic indications

Name of medicine	Avastin
INN	bevacizumab
Marketing-authorisation holder	Roche Registration Limited
More information	CHMP post-authorisation summary of positive opinion for Avastin (II/0092)

 

Name of medicine	Celsentri
INN	maraviroc
Marketing-authorisation holder	ViiV Healthcare UK Limited
More information	CHMP post-authorisation summary of positive opinion for Celsentri (X-46-G)

 

Name of medicine	Opdivo
INN	nivolumab
Marketing-authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	CHMP post-authorisation summary of positive opinion for Opdivo

 

Outcomes of harmonisation procedures

Name of medicine	Etopophos and associated names
INN	etoposide
Marketing-authorisation holder	Bristol-Myers Squibb group of companies and associated companies
More information	Questions and answers on Etopophos and associated names

 

Name of medicine	Vepesid and associated names
INN	etoposide
Marketing-authorisation holder	Bristol-Myers Squibb group of companies and associated companies
More information	Questions and answers on Vepesid and associated names

 

Withdrawal of application

Name of medicine	Solithromycin Triskel EU Services
INN	solithromycin
More information	Questions and answers on Solithromycin Triskel EU Services

 

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 18-21 April 2017

Overview of (invented) names reviewed in March 2017 by the Name Review Group (NRG)

Scientific advice and protocol assistance adopted during the CHMP meeting 18 – 21 April 2017

Start of Community reviews