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

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24/03/2017

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.

CHMP_highlights_March_2017

Download image in pdf format

Positive recommendations on new medicines

Name of medicineAxumin
INNfluciclovine (18F)
Marketing authorisation applicantBlue Earth Diagnostics Ltd
Therapeutic indicationDiagnostic agent for the detection of recurrence of prostate cancer with positron emission tomography (PET) imaging
More informationSummary of opinion for Axumin

 

Name of medicineDintuximab beta Apeiron
INNdinutuximab beta
Marketing authorisation applicantApeiron Biologics AG
Therapeutic indicationTreatment of high-risk neuroblastoma
More informationSummary of opinion for Dintuximab beta Apeiron

 

Name of medicineElmiron
INNpentosan polysulfate sodium
Marketing authorisation applicantbene-Arzneimittel GmbH
Therapeutic indicationTreatment of bladder pain syndrome characterised by either glomerulations or Hunner’s lesions
More informationSummary of opinion for Elmiron

 

Name of medicineRefixia
INNnonacog beta pegol
Marketing authorisation applicantNovo Nordisk A/S
Therapeutic indicationTreatment of haemophilia B
More informationSummary of opinion for Refixia

 

Name of medicineTrumenba
Common namemeningococcal group B vaccine (recombinant, adsorbed)
Marketing authorisation applicantPfizer Limited
Therapeutic indicationProphylaxis against invasive meningococcal disease caused by meningococcal serogroup B bacteria
More informationSummary of opinion for Trumenba

 

Positive recommendation on new generic medicine

Name of medicineIvabradine Accord
INNivabradine
Marketing authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of angina pectoris and chronic heart failure
More informationSummary of opinion for Ivabradine Accord

 

Positive recommendations on extensions of therapeutic indications

Name of medicine Keytruda
INNpembrolizumab
Marketing authorisation holderMerck Sharp & Dohme Limited
More informationSummary of opinion for Keytruda

 

Name of medicine Opdivo
INNnivolumab
Marketing authorisation holderBristol-Myers Squibb Pharma EEIG
More informationSummary of opinion for Opdivo

              

Name of medicine Zebinix
INNeslicarbazepine acetate
Marketing authorisation holderBial - Portela & Cª, S.A.
More informationSummary of opinion for Zebinix

 

Public health recommendation

Name of medicineMicro Therapeutics Research Labs, India
More informationEMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs

 

Withdrawals of applications

Name of medicine Blectifor
INNcaffeine citrate
Marketing authorisation applicantViridian Pharma Ltd
More informationQuestions and answers on Blectifor

 

Name of medicineEnpaxiq
INNpacritinib
Marketing authorisation applicantCTI Life Sciences Limited
More informationQuestions and answers on Enpaxiq

 

Name of medicineTranslarna
INNataluren
Marketing authorisation holderPTC Therapeutics International Limited
More informationQuestions and answers on Translarna

 

Other updates

Recommendations on eligibility to PRIME scheme
Scientific advice and protocol assistance
Start of community reviews

 

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