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

  • Email
  • Help

News

22/05/2015

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.

 

Download image in PDF format

 

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 informationSummary of opinion for Evotaz

  

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

Summary 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

Summary 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 informationSummary of opinion for Omidria

 

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

Summary 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

Summary 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 informationSummary of opinion for Bortezomib Accord

  

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

 

Positive recommendation on new therapeutic indications   

Name of medicineFycompa
INNperampanel  
Marketing-authorisation holderEisai Europe Ltd
More informationSummary of opinion for Fycompa

 

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

Summary of opinion for Imbruvica

 

Press release: First medicine for rare blood cancer

   

Name of medicineKuvan
INNsapropterin
Marketing-authorisation holderMerck Serono Europe Limited
More informationSummary of opinion for Kuvan

  

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

   

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

  

Name of medicineXultophy
INNinsulin degludec / liraglutide
Marketing-authorisation holderNovo Nordisk A/S
More informationSummary 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 informationQuestions and answers on Aripiprazole Mylan

 

Name of medicineCorluxin
INNmifepristone
More informationQuestions and answers on Corluxin

 

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
Organisational matters

How useful is this page?

Average rating:

 Based on 5 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
1 ratings
4 ratings
0 ratings

Related content

Please note that not all documents associated with this page are published at the same time. This page is updated with new documents as soon as they become available. Therefore, users are asked to check the page regularly.

Contact point:

Monika Benstetter
Tel. +44 (0)20 3660 8427
E-mail: press@ema.europa.eu