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

24 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 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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive 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 refusal of a change to the marketing authorisation for Lympreva (dasiprotimut-T)

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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP summary of positive 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	CHMP post-authorisation summary of positive opinion for Esmya

Name of medicine	Invega
INN	paliperidone
Marketing-authorisation holder	Janssen-Cilag International N.V.
More information	CHMP post-authorisation summary of positive opinion for Invega

Name of medicine	Levemir
INN	insulin detemir
Marketing-authorisation holder	Novo Nordisk A/S
More information	CHMP post-authorisation summary of positive opinion for Levemir

Name of medicine	Relistor
INN	methylnaltrexone bromide
Marketing-authorisation holder	TMC Pharma Services Ltd
More information	CHMP post-authorisation summary of positive opinion for Relistor

Name of medicine	Resolor
INN	prucalopride
Marketing-authorisation holder	Shire Pharmaceuticals Ireland Ltd
More information	CHMP post-authorisation summary of positive opinion for Resolor

Name of medicine	Tygacil
INN	tigecycline
Marketing-authorisation holder	Pfizer Limited
More information	CHMP post-authorisation summary of positive 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 the withdrawal of the marketing authorisation application for Duloxetine Sandoz (duloxetine)

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures adopted at the CHMP meeting of 20-23 April 2015

Opinions on safety variations/periodic safety update reports adopted at the CHMP meeting of 20-23 April 2015

Scientific advice and protocol assistance adopted during the CHMP meeting 20-23 April 2015

Guidelines and concept papers adopted during the CHMP meeting 20-23 April 2015

Overview of (invented) names reviewed in March 2015 by the Name Review Group (NRG) adopted at the CHMP meeting of 20-23 April 2015

Organisational matters - CHMP meeting 20-23 April 2015

Opinions on consultation procedures on ancillary medicinal substances in medical devices