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

News 24/04/2015

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.

 April 2015

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

PDF iconSummary 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 information PDF iconSummary 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 information PDF iconSummary 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

PDF iconSummary 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 information PDF iconQuestions 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 information PDF iconSummary 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 information PDF iconSummary 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 information PDF iconSummary of opinion for Duloxetine Mylan

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

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

Positive recommendation on new therapeutic indications

Name of medicineEsmya
INNulipristal
Marketing-authorisation holderGedeon Richter Plc
More information PDF iconSummary of opinion for Esmya

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

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

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

Name of medicineResolor
INNprucalopride
Marketing-authorisation holderShire Pharmaceuticals Ireland Ltd
More information PDF iconSummary of opinion for Resolor

Name of medicineTygacil
INNtigecycline
Marketing-authorisation holderPfizer Limited
More information PDF iconSummary 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 information PDF iconQuestions and answers on Duloxetine Sandoz

Other updates

PDF iconOpinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
Start of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
PDF iconOverview of invented names reviewed in March 2015 by the Name Review Group (NRG)
PDF iconOrganisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

How useful was this page?

Add your rating