Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015

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24/04/2015

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015

Eleven new medicines, including one orphan, recommended for approval

Eleven new medicines were recommended for approval at the April 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).

The CHMP recommended granting a marketing authorisation for Opdivo (nivolumab), for the treatment of adults with advanced (unresectable or metastatic) melanoma. For more information on Opdivo, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Hetlioz (tasimelteon) to treat non-24-hour sleep-wake disorder in totally blind adults. Hetlioz was granted orphan designation in 2011. For more information on Hetlioz, please see the press release in the grid below.

Lixiana (edoxaban) received a positive opinion from the Committee for the prevention of stroke and systemic embolism in atrial fibrillation, and the prevention and treatment of venous thromboembolism.

LuMark (Lutetium (177Lu) chloride), a radiopharmaceutical precursor, received a position opinion from the CHMP for the radiolabelling of carrier molecules.

The following seven generic medicines received a positive opinion from the CHMP: Aripiprazole Pharmathen (aripiprazole) for the treatment of schizophrenia and treatment and prevention of manic episodes of bipolar 1 disorder; Aripiprazole Zentiva (aripiprazole) for the treatment of schizophrenia and treatment and prevention of manic episodes in bipolar 1 disorder; Duloxetine Mylan (duloxetine) for the treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder; Pregabalin Mylan (pregabalin) for the treatment of epilepsy and generalised anxiety disorder; Pregabalin Mylan Pharma (pregabalin) for the treatment of neuropathic pain, epilepsy and generalised anxiety disorder; Pregabalin Sandoz (pregabalin) for the treatment of epilepsy, neuropathic pain and generalised anxiety disorder and Pregabalin Sandoz GmbH for the treatment of epilepsy and generalised anxiety disorder.

Negative opinion on new medicine

The CHMP adopted a negative opinion for Lympreva (dasiprotimut-T) which was intended for the treatment of patients with follicular non-Hodgkin’s lymphoma.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Esmya, Invega, Levemir, Relistor, Resolor and Tygacil.

CHMP recommends avoiding use of certain hepatitis C medicines with amiodarone

The CHMP confirmed a risk of severe bradycardia or heart block when the hepatitis C medicines Harvoni (sofosbuvir with ledipasvir) or a combination of Sovaldi (sofosbuvir) and Daklinza (daclatasvir) are used in patients who are also taking the antiarrhythmic amiodarone. To manage this risk, the CHMP recommends that in patients taking these medicines, amiodarone should only be used if other antiarrhythmics cannot be given. For more information, please see the public health communication in the grid below.

Withdrawal of application

The application for marketing authorisation for Duloxetine Sandoz (duloxetine) has been withdrawn.

A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

The agenda of the April 2015 meeting is published on EMA’s website. The minutes of the meeting will be published during the week following the May CHMP meeting.

CHMP statistics

Key figures from the April 2015 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s April 2015 meeting, is available in the grid below.

 

 

Positive recommendations on new medicines

Name of medicineHetlioz
International non-proprietary name (INN)tasimelteon 
Marketing-authorisation applicantVanda Pharmaceuticals Ltd 
Therapeutic indicationTreatment of non-24-hour sleep-wake disorder (non-24) in totally blind adults
More information

Summary of opinion for Hetlioz

 

Press release: First EU treatment for rare sleep-wake disorder

 

Name of medicineLixiana
INNedoxaban
Marketing-authorisation applicantDaiichi Sankyo Europe GmbH 
Therapeutic indicationPrevention of stroke and systemic embolism in atrial fibrillation
Prevention and treatment of venous thromboembolism
More informationSummary of opinion for Lixiana

 

Name of medicineLumark
INNLutetium (177Lu) chloride
Marketing-authorisation applicantI.D.B. Radiopharmacy B.V. 
Therapeutic indicationUsed only for the radiolabelling of carrier molecules 
More informationSummary of opinion for Lumark

 

Name of medicineOpdivo
INNnivolumab 
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG 
Therapeutic indicationTreatment of advanced (unresectable or metastatic) melanoma in adults 
More information

Summary of opinion for Opdivo

 

Press release: New treatment for advanced melanoma

 

Negative recommendation on new medicine   

Name of medicineLympreva
INNdasiprotimut-t 
Marketing-authorisation applicantBiovest Europe Ltd 
Therapeutic indicationTreatment of non-Hodgkin’s lymphoma (FL) 
More informationQuestions and answers on Lympreva

 

Positive recommendations on new generic medicines

Name of medicineAripiprazole Pharmathen
INNaripiprazole 
Marketing-authorisation applicantPharmathen S.A. 
Therapeutic indicationTreatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder 
More informationSummary of opinion for Aripiprazole Pharmathen

 

Name of medicineAripiprazole Zentiva
INNaripiprazole 
Marketing-authorisation applicantZentiva, k.s. 
Therapeutic indicationTreatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder
More informationSummary of opinion for Aripiprazole Zentiva

 

Name of medicineDuloxetine Mylan
INNduloxetine 
Marketing-authorisation applicantGenerics UK Limited
Therapeutic indicationTreatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder
More informationSummary of opinion for Duloxetine Mylan

  

Name of medicinePregabalin Mylan
INNpregabalin 
Marketing-authorisation applicantGenerics UK Limited 
Therapeutic indicationTreatment of epilepsy and generalised anxiety disorder
More informationSummary of opinion for Pregabalin Mylan

 

Name of medicinePregabalin Mylan Pharma
INNpregabalin 
Marketing-authorisation applicantGenerics UK Limited 
Therapeutic indicationTreatment of neuropathic pain, epilepsy and generalised anxiety disorder  
More informationSummary of opinion for Pregabalin Mylan Pharma

 

Name of medicinePregabalin Sandoz
INNpregabalin 
Marketing-authorisation applicantSandoz GmbH 
Therapeutic indicationTreatment of neuropathic pain, epilepsy and generalised anxiety disorder 
More informationSummary of opinion for Pregabalin Sandoz

 

Name of medicinePregabalin Sandoz GmbH
INNpregabalin 
Marketing-authorisation applicantSandoz GmbH  
Therapeutic indicationTreatment of epilepsy and generalised anxiety disorder  
More informationSummary of opinion for Pregabalin Sandoz GmbH

 

Positive recommendation on new therapeutic indications

Name of medicineEsmya
INNulipristal 
Marketing-authorisation holderGedeon Richter Plc 
More informationSummary of opinion for Esmya

 

Name of medicineInvega
INNpaliperidone 
Marketing-authorisation holderJanssen-Cilag International N.V. 
More informationSummary of opinion for Invega

 

Name of medicineLevemir
INNinsulin detemir 
Marketing-authorisation holderNovo Nordisk A/S 
More informationSummary of opinion for Levemir

  

Name of medicineRelistor
INNmethylnaltrexone bromide 
Marketing-authorisation holderTMC Pharma Services Ltd 
More informationSummary of opinion for Relistor

 

Name of medicineResolor
INNprucalopride 
Marketing-authorisation holderShire Pharmaceuticals Ireland Ltd 
More informationSummary of opinion for Resolor

 

Name of medicineTygacil
INNtigecycline 
Marketing-authorisation holderPfizer Limited 
More informationSummary of opinion for Tygacil

 

Public health recommendation

Name of medicineSovaldi, Daklinza, Harvoni
More informationEMA recommends avoidance of certain hepatitis C medicines and amiodarone together

 

Outcome of arbitration procedure

Name of medicineMerisone and Myoson
INNtolperisone 
Marketing-authorisation holderMeditop Pharmaceutical Co Ltd 
More informationQuestions and answers on Merisone and Myoson

 

Withdrawal of application 

Name of medicineDuloxetine Sandoz
INNduloxetine 
More informationQuestions and answers on Duloxetine Sandoz

  

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Overview of invented names reviewed in March 2015 by the Name Review Group (NRG)
Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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