Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 March 2017

Six medicines recommended for approval, including three orphans

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval at its March 2017 meeting.

The CHMP recommended granting a marketing authorisation under exceptional circumstances for Dinutuximab beta Apeiron (dinutuximab beta) for the treatment of high-risk neuroblastoma. This medicine has an orphan designation. Authorisation under exceptional circumstances allows patients access to medicines that cannot be approved under a standard authorisation as comprehensive data cannot be obtained, either because there are only very few patients with the disease, the collection of complete information on the efficacy and safety of the medicine would be unethical, or there are gaps in the scientific knowledge. These medicines are subject to specific post-authorisation obligations and monitoring.

The Committee granted a positive opinion for Refixia (nonacog beta pegol) for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia B (congenital factor IX deficiency). Refixia has an orphan designation.

The CHMP granted a positive opinion for Elmiron (pentosan polysulfate sodium) for the treatment of bladder pain syndrome characterised by either glomerulations or Hunner's lesions (tiny bleeds or distinctive lesions on the bladder wall). Elmiron has an orphan designation.

Trumenba, a meningococcal group B vaccine (recombinant, adsorbed) to prevent invasive meningococcal disease caused by meningococcal serogroup B bacteria, received a positive opinion from the Committee.

A diagnostic agent, Axumin (fluciclovine (18F)), was recommended for marketing authorisation by the Committee for the detection of recurrence of prostate cancer with positron emission tomography (PET) imaging.

A generic medicine, Ivabradine Accord (ivabradine), received a positive opinion from the Committee for the treatment of angina pectoris and chronic heart failure.

Three recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Keytruda, Opdivo and Zebinix.

Withdrawals of applications

Applications for initial marketing authorisations for Blectifor (caffeine citrate) and Enpaxiq (pacritinib) have been withdrawn.

An application to extend the indication of Translarna (ataluren) to treat cystic fibrosis has also been withdrawn.

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

CHMP recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs

The CHMP recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. The suspensions can be lifted once alternative data establishing bioequivalence are provided. More information, including the list of medicines recommended for suspension, is available in the public health communication in the grid below.

Agenda and minutes

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

CHMP statistics

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

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

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Positive recommendations on new medicines

Name of medicine	Axumin
INN	fluciclovine (18F)
Marketing authorisation applicant	Blue Earth Diagnostics Ltd
Therapeutic indication	Diagnostic agent for the detection of recurrence of prostate cancer with positron emission tomography (PET) imaging
More information	Summary of opinion for Axumin

Name of medicine	Dintuximab beta Apeiron
INN	dinutuximab beta
Marketing authorisation applicant	Apeiron Biologics AG
Therapeutic indication	Treatment of high-risk neuroblastoma
More information	Summary of opinion for Dintuximab beta Apeiron

Name of medicine	Elmiron
INN	pentosan polysulfate sodium
Marketing authorisation applicant	bene-Arzneimittel GmbH
Therapeutic indication	Treatment of bladder pain syndrome characterised by either glomerulations or Hunner's lesions
More information	Summary of opinion for Elmiron

Name of medicine	Refixia
INN	nonacog beta pegol
Marketing authorisation applicant	Novo Nordisk A/S
Therapeutic indication	Treatment of haemophilia B
More information	Summary of opinion for Refixia

Name of medicine	Trumenba
Common name	meningococcal group B vaccine (recombinant, adsorbed)
Marketing authorisation applicant	Pfizer Limited
Therapeutic indication	Prophylaxis against invasive meningococcal disease caused by meningococcal serogroup B bacteria
More information	Summary of opinion for Trumenba

Positive recommendation on new generic medicine

Name of medicine	Ivabradine Accord
INN	ivabradine
Marketing authorisation applicant	Accord Healthcare Ltd
Therapeutic indication	Treatment of angina pectoris and chronic heart failure
More information	Summary of opinion for Ivabradine Accord

Positive recommendations on extensions of therapeutic indications

Name of medicine	Keytruda
INN	pembrolizumab
Marketing authorisation holder	Merck Sharp & Dohme Limited
More information	Summary of opinion for Keytruda

Name of medicine	Opdivo
INN	nivolumab
Marketing authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	Summary of opinion for Opdivo

Name of medicine	Zebinix
INN	eslicarbazepine acetate
Marketing authorisation holder	Bial - Portela & Cª, S.A.
More information	Summary of opinion for Zebinix

Public health recommendation

Withdrawals of applications

Name of medicine	Blectifor
INN	caffeine citrate
Marketing authorisation applicant	Viridian Pharma Ltd
More information	Questions and answers on Blectifor

Name of medicine	Enpaxiq
INN	pacritinib
Marketing authorisation applicant	CTI Life Sciences Limited
More information	Questions and answers on Enpaxiq

Name of medicine	Translarna
INN	ataluren
Marketing authorisation holder	PTC Therapeutics International Limited
More information	Questions and answers on Translarna

Other updates

Recommendations on eligibility to PRIME scheme

Scientific advice and protocol assistance

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