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

News 22/05/2015

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

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Positive recommendations on new medicines

Name of medicineEvotaz
International non-proprietary name (INN)atazanavir / cobicistat
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG
Therapeutic indicationTreatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir
More information PDF iconSummary of opinion for Evotaz

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation applicantMerck Sharp & Dohme Limited
Therapeutic indicationTreatment of melanoma
More information

PDF iconSummary of opinion for Keytruda

Press release: New treatment option recommended for patients with advanced melanoma

Name of medicineNivolumab BMS
INNnivolumab
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG
Therapeutic indicationTreatment of adults with squamous non-small cell lung cancer (NSCLC)
More information

PDF iconSummary of opinion for Nivolumab BMS

Press release: New treatment option for patients with advanced lung cancer

Name of medicineOmidria
INNphenylephrine / ketorolac
Marketing-authorisation applicantOmeros London Limited
Therapeutic indicationMaintenance of intraoperative mydriasis, prevention of intraoperative miosis and reduction of acute postoperative ocular pain in intraocular lens replacement surgery in adults
More information PDF iconSummary of opinion for Omidria

Name of medicineRepatha
INNevolocumab
Marketing-authorisation applicantAmgen Europe B.V.
Therapeutic indicationHypercholesterolaemia, mixed dyslipidaemia and homozygous familial hypercholesterolaemia
More information

PDF iconSummary of opinion for Repatha

Press release: First-in-class treatment to lower cholesterol

Name of medicineUnituxin
INNdinutuximab
Marketing-authorisation applicantUnited Therapeutics Europe Ltd
Therapeutic indicationTreatment of high-risk neuroblastoma
More information

PDF iconSummary of opinion for Unituxin

Press release: EMA recommends treatment for rare cancer in children

Positive recommendations on new generic medicines

Name of medicineBortezomib Accord
INNbortezomib
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationTreatment of multiple myeloma
More information PDF iconSummary of opinion for Bortezomib Accord

Name of medicinePregabalin Zentiva
INNpregabalin
Marketing-authorisation applicantZentiva, k.s.
Therapeutic indicationTreatment of epilepsy and generalised anxiety disorder
More information PDF iconSummary of opinion for Pregabalin Zentiva

Positive recommendation on new therapeutic indications

Name of medicineFycompa
INNperampanel
Marketing-authorisation holderEisai Europe Ltd
More information PDF iconSummary of opinion for Fycompa

Name of medicineImbruvica
INNibrutinib
Marketing-authorisation holderJanssen-Cilag International NV
More information

PDF iconSummary of opinion for Imbruvica

Press release: First medicine for rare blood cancer

Name of medicineKuvan
INNsapropterin
Marketing-authorisation holderMerck Serono Europe Limited
More information PDF iconSummary of opinion for Kuvan

Name of medicineSimponi
INNgolimumab
Marketing-authorisation holderJanssen Biologics B.V.
More information PDF iconSummary of opinion for Simponi

Name of medicineStelara
INNustekinumab
Marketing-authorisation holderJanssen-Cilag International N.V.
More information PDF iconSummary of opinion for Stelara

Name of medicineXultophy
INNinsulin degludec / liraglutide
Marketing-authorisation holderNovo Nordisk A/S
More information PDF iconSummary of opinion for Xultophy

Public health recommendation

Name of medicineGVK Biosciences
More informationGVK Biosciences: European Medicines Agency confirms recommendation to suspend medicines over flawed studies

Withdrawal of application

Name of medicineAripiprazole Mylan
INNaripiprazole
More information PDF iconQuestions and answers on Aripiprazole Mylan

Name of medicineCorluxin
INNmifepristone
More information PDF iconQuestions and answers on Corluxin

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 iconOrganisational matters

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