Eleven new medicines, including one orphan, recommended for approval

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

 

London (April 24, 2015) – 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.

 

 

Photo: EMA

 

 

Positive recommendations on new medicines

 

Name of medicine

Hetlioz

International non-proprietary name (INN)

tasimelteon 

Marketing-authorisation applicant

Vanda Pharmaceuticals Ltd 

Therapeutic indication

Treatment 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 medicine

Lixiana

INN

edoxaban

Marketing-authorisation applicant

Daiichi Sankyo Europe GmbH 

Therapeutic indication

Prevention of stroke and systemic embolism in atrial fibrillation
Prevention and treatment of venous thromboembolism

More information

Summary of opinion for Lixiana

 

Name of medicine

Lumark

INN

Lutetium (177Lu) chloride

Marketing-authorisation applicant

I.D.B. Radiopharmacy B.V. 

Therapeutic indication

Used only for the radiolabelling of carrier molecules 

More information

Summary of opinion for Lumark

 

Name of medicine

Opdivo

INN

nivolumab 

Marketing-authorisation applicant

Bristol-Myers Squibb Pharma EEIG 

Therapeutic indication

Treatment 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 medicine

Lympreva

INN

dasiprotimut-t 

Marketing-authorisation applicant

Biovest Europe Ltd 

Therapeutic indication

Treatment of non-Hodgkin’s lymphoma (FL) 

More information

Questions and answers on Lympreva

 

 

Positive recommendations on new generic medicines

 

Name of medicine

Aripiprazole Pharmathen

INN

aripiprazole 

Marketing-authorisation applicant

Pharmathen S.A. 

Therapeutic indication

Treatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder 

More information

Summary of opinion for Aripiprazole Pharmathen

 

Name of medicine

Aripiprazole Zentiva

INN

aripiprazole 

Marketing-authorisation applicant

Zentiva, k.s. 

Therapeutic indication

Treatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder

More information

Summary of opinion for Aripiprazole Zentiva

 

Name of medicine

Duloxetine Mylan

INN

duloxetine 

Marketing-authorisation applicant

Generics UK Limited

Therapeutic indication

Treatment of major depressive disorder, diabetic peripheral neuropathic pain and generalised anxiety disorder

More information

Summary of opinion for Duloxetine Mylan

  

Name of medicine

Pregabalin Mylan

INN

pregabalin 

Marketing-authorisation applicant

Generics UK Limited 

Therapeutic indication

Treatment of epilepsy and generalised anxiety disorder

More information

Summary of opinion for Pregabalin Mylan

 

Name of medicine

Pregabalin Mylan Pharma

INN

pregabalin 

Marketing-authorisation applicant

Generics UK Limited 

Therapeutic indication

Treatment of neuropathic pain, epilepsy and generalised anxiety disorder  

More information

Summary of opinion for Pregabalin Mylan Pharma

 

Name of medicine

Pregabalin Sandoz

INN

pregabalin 

Marketing-authorisation applicant

Sandoz GmbH 

Therapeutic indication

Treatment of neuropathic pain, epilepsy and generalised anxiety disorder 

More information

Summary of opinion for Pregabalin Sandoz

 

Name of medicine

Pregabalin Sandoz GmbH

INN

pregabalin 

Marketing-authorisation applicant

Sandoz GmbH  

Therapeutic indication

Treatment of epilepsy and generalised anxiety disorder  

More information

Summary of opinion for Pregabalin Sandoz GmbH

 

 

Positive recommendation on new therapeutic indications

 

Name of medicine

Esmya

INN

ulipristal 

Marketing-authorisation holder

Gedeon Richter Plc 

More information

Summary of opinion for Esmya

 

Name of medicine

Invega

INN

paliperidone 

Marketing-authorisation holder

Janssen-Cilag International N.V. 

More information

Summary of opinion for Invega

 

Name of medicine

Levemir

INN

insulin detemir 

Marketing-authorisation holder

Novo Nordisk A/S 

More information

Summary of opinion for Levemir

  

Name of medicine

Relistor

INN

methylnaltrexone bromide 

Marketing-authorisation holder

TMC Pharma Services Ltd 

More information

Summary of opinion for Relistor

 

Name of medicine

Resolor

INN

prucalopride 

Marketing-authorisation holder

Shire Pharmaceuticals Ireland Ltd 

More information

Summary of opinion for Resolor

 

Name of medicine

Tygacil

INN

tigecycline 

Marketing-authorisation holder

Pfizer Limited 

More information

Summary of opinion for Tygacil

 

 

Public health recommendation

 

Name of medicine

Sovaldi, Daklinza, Harvoni

More information

EMA recommends avoidance of certain hepatitis C medicines and amiodarone together

 

 

Outcome of arbitration procedure

 

Name of medicine

Merisone and Myoson

INN

tolperisone 

Marketing-authorisation holder

Meditop Pharmaceutical Co Ltd 

More information

Questions and answers on Merisone and Myoson

 

 

Withdrawal of application 

 

Name of medicine

Duloxetine Sandoz

INN

duloxetine 

More information

Questions 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

 

 


European Medicines Agency, 24.04.2015 (tB).

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