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

 

London, UK (May 22, 2015) – 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.

T
hree 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_highlights_May_2015. Graphic: EMA 

 

 

Download image in PDF format

 

 

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

Summary of opinion for Evotaz

  

Name of medicine

Keytruda

INN

pembrolizumab

Marketing-authorisation applicant

Merck Sharp & Dohme Limited

Therapeutic indication

Treatment of melanoma

More information

Summary of 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

Summary of 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

Summary of 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

Summary of 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

Summary of 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

Summary of 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

Summary of opinion for Pregabalin Zentiva

 

 

Positive recommendation on new therapeutic indications   

 

Name of medicine

Fycompa

INN

perampanel  

Marketing-authorisation holder

Eisai Europe Ltd

More information

Summary of opinion for Fycompa

 

Name of medicine

Imbruvica

INN

ibrutinib

Marketing-authorisation holder

Janssen-Cilag International NV

More information

Summary of 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

Summary of opinion for Kuvan

  

Name of medicine

Simponi

INN

golimumab

Marketing-authorisation holder

Janssen Biologics B.V.

More information

Summary of opinion for Simponi

   

Name of medicine

Stelara

INN

ustekinumab

Marketing-authorisation holder

Janssen-Cilag International N.V.

More information

Summary of opinion for Stelara

  

Name of medicine

Xultophy

INN

insulin degludec / liraglutide

Marketing-authorisation holder

Novo Nordisk A/S

More information

Summary of 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 Aripiprazole Mylan

 

Name of medicine

Corluxin

INN

mifepristone

More information

Questions and answers on Corluxin

 

 

Other updates

 

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures

 

  • Opinions on safety variations
  • Guidelines and concept papers adopted
  • Organisational matters
  • Opinions on consultation procedures on ancillary medicinal substances in medical devices

 

 


European Medicines Agency (EMA), 22.05.2015 (tB).

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