Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 May 2015

Eight new medicines, including three cancer immunotherapies, recommended for approval

Eight new medicines have been recommended for approval at the May 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP).

The Committee has recommended granting a marketing authorisation for Repatha (evolocumab), a first-in-class treatment to lower high levels of cholesterol in the blood of people who are unable to control their cholesterol despite taking optimal doses of statins or who cannot take statins. Repatha is also recommended to treat homozygous familial hypercholesterolaemia, a rare inherited disorder. Repatha is the first monoclonal antibody in this therapeutic area and provides a new treatment option for patients who are unable to control their high cholesterol despite taking currently available therapies. For more information on Repatha, please see the press release in the grid below.

Three immunotherapies for the treatment of different types of cancer were granted a positive opinion by the CHMP: Keytruda (pembrolizumab) to treat advanced (unresectable or metastatic) melanoma, Nivolumab BMS (nivolumab) to treat adults with squamous non-small cell lung cancer (NSCLC) and Unituxin (dinutiximab) for the treatment of high-risk neuroblastoma - a type of cancer that most often occurs in young children. Unituxin was granted an orphan designation in 2011. Cancer immunotherapies are treatments that use the body's own immune system to fight the disease. For more information on these cancer medicines, please see the press releases in the grid below.

The CHMP recommended Evotaz (atazanavir / cobicistat) intended for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir.

Omidria (phenylephrine / ketorolac) received a positive opinion from the Committee for maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery.

Two generic medicines received positive opinions from the CHMP: Bortezomib Accord (bortezomib) for the treatment of multiple myeloma and mantle cell lymphoma and Pregabalin Zentiva (pregabalin) for the treatment of epilepsy and generalised anxiety disorder.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Fycompa, Imbruvica, Kuvan, Simponi, Stelara and Xultophy. For more information on the extension of indication for Imbruvica, please see the press release in the grid below.

Outcome of re-examination of GVK Bio Sciences

The CHMP has confirmed its recommendation to suspend a number of medicines for which authorisation in the European Union were primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India. This is the outcome of a re-examination requested by marketing authorisation holders for seven of the medicines concerned.

Withdrawal of applications

The applications for marketing authorisation for Aripiprazole Mylan (aripiprazole) and Corluxin (mifepristone) have been withdrawn.

Question-and-answer documents on these withdrawals are available in the grid below.

Agenda and minutes

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

CHMP statistics

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

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

CHMP statistics: May 2015

Positive recommendations on new medicines

Name of medicine	Evotaz
International non-proprietary name (INN)	atazanavir / cobicistat
Marketing-authorisation applicant	Bristol-Myers Squibb Pharma EEIG
Therapeutic indication	Treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir
More information	CHMP summary of positive opinion for Evotaz

Name of medicine	Keytruda
INN	pembrolizumab
Marketing-authorisation applicant	Merck Sharp & Dohme Limited
Therapeutic indication	Treatment of melanoma
More information	CHMP summary of positive opinion for Keytruda Press release: New treatment option recommended for patients with advanced melanoma

Name of medicine	Nivolumab BMS
INN	nivolumab
Marketing-authorisation applicant	Bristol-Myers Squibb Pharma EEIG
Therapeutic indication	Treatment of adults with squamous non-small cell lung cancer (NSCLC)
More information	CHMP summary of positive opinion for Nivolumab BMS Press release: New treatment option for patients with advanced lung cancer

Name of medicine	Omidria
INN	phenylephrine / ketorolac
Marketing-authorisation applicant	Omeros London Limited
Therapeutic indication	Maintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery in adults
More information	CHMP summary of positive opinion for Omidria

Name of medicine	Repatha
INN	evolocumab
Marketing-authorisation applicant	Amgen Europe B.V.
Therapeutic indication	Hypercholesterolaemia, mixed dyslipidaemia and homozygous familial hypercholesterolaemia
More information	CHMP summary of positive opinion for Repatha Press release: First-in-class treatment to lower cholesterol

Name of medicine	Unituxin
INN	dinutuximab
Marketing-authorisation applicant	United Therapeutics Europe Ltd
Therapeutic indication	Treatment of high-risk neuroblastoma
More information	CHMP summary of positive opinion for Unituxin Press release: EMA recommends treatment for rare cancer in children

Positive recommendations on new generic medicines

Name of medicine	Bortezomib Accord
INN	bortezomib
Marketing-authorisation applicant	Accord Healthcare Ltd
Therapeutic indication	Treatment of multiple myeloma
More information	CHMP summary of positive opinion for Bortezomib Accord

Name of medicine	Pregabalin Zentiva
INN	pregabalin
Marketing-authorisation applicant	Zentiva, k.s.
Therapeutic indication	Treatment of epilepsy and generalised anxiety disorder
More information	CHMP summary of positive opinion for Pregabalin Zentiva

Positive recommendation on new therapeutic indications

Name of medicine	Fycompa
INN	perampanel
Marketing-authorisation holder	Eisai Europe Ltd
More information	CHMP post-authorisation summary of positive opinion for Fycompa

Name of medicine	Imbruvica
INN	ibrutinib
Marketing-authorisation holder	Janssen-Cilag International NV
More information	CHMP post-authorisation summary of positive opinion for Imbruvica Press release: First medicine for rare blood cancer

Name of medicine

Imbruvica

INN

ibrutinib

Marketing-authorisation holder

Janssen-Cilag International NV

More information

CHMP post-authorisation summary of positive opinion for Imbruvica

Press release: First medicine for rare blood cancer

Name of medicine	Kuvan
INN	sapropterin
Marketing-authorisation holder	Merck Serono Europe Limited
More information	CHMP post-authorisation summary of positive opinion for Kuvan

Name of medicine	Simponi
INN	golimumab
Marketing-authorisation holder	Janssen Biologics B.V.
More information	CHMP post-authorisation summary of positive opinion for Simponi

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

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

Public health recommendation

Name of medicine	GVK Biosciences
More information	GVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines over flawed studies

Withdrawal of application

Name of medicine	Aripiprazole Mylan
INN	aripiprazole
More information	Questions and answers on the withdrawal of the marketing authorisation application for Aripiprazole Mylan (aripiprazole)