Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 2014

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24/01/2014

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 January 2014

This page provides an overview of the opinions adopted at the January 2014 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Six new medicines recommended for approval

The CHMP recommended granting a marketing authorisation for Eperzan (albiglutide), for the treatment of type 2 diabetes.

The Committee gave a positive recommendation for Adempas (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Adempas has an orphan designation.

The Committee recommended the granting of a marketing authorisation for Latuda (lurasidone) for the treatment of schizophrenia.

The Committee gave a positive recommendation for Bemfola (follitropin alfa), a new biosimilar medicine for the treatment of infertility.

Two generic medicines were also recommended for approval by the CHMP: Rivastigmine 3M Health Care Ltd for the treatment of Alzheimer’s dementia and Zoledronic acid Teva Generics for the treatment of osteoporosis and Paget’s disease of the bone.

Positive scientific opinion on Hemoprostol

The CHMP also recommended the approval of Hemoprostol (misoprostol), indicated for the treatment of post-partum haemorrhage due to uterine atony in situations where intravenous oxytocin is not available. Hemoprostol will be intended exclusively for markets outside the European Union.

Four negative opinions on new medicines

The Committee adopted four negative opinions in January 2014, including opinions for Nerventra, which was intended for the treatment of multiple sclerosis and Reasanz, which was intended for the treatment of acute heart failure. The Committee also issued negative opinions for two orphan medicines, Masiviera which was intended for the treatment of non resectable locally advanced or metastatic pancreatic cancer and Translarna which was intended for the treatment of Duchenne muscular dystrophy.

Three recommendations on extensions of therapeutic indications

The CHMP recommended extensions of indications for NovoThirteen, Stelara and Xolair.

Review of emergency contraceptives started

The CHMP started a review of emergency contraceptives to assess whether increased bodyweight and body mass index (BMI) reduce the efficacy of these medicines in preventing an unintended pregnancy following unprotected sexual intercourse or contraceptive failure. Please see press release Review of emergency contraceptives started for more details.

Update on safety review of Protelos / Osseor

The recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) that Protelos and Osseor should no longer be used to treat osteoporosis is still under consideration by the CHMP. At its January 2014 meeting the Committee requested additional information from the company to inform its scientific decision-making. A final opinion will be made by the CHMP at its meeting in February 2014.

Request for re-examination of CHMP recommendation of topical estradiol-containing medicines

The marketing authorisation holder for Linoladiol N and Linoladiol HN has requested a re-examination of the CHMP’s December 2013 opinion on Linoladiol N. Upon receipt of the grounds of the request for re-examination, the CHMP will re-examine its opinion and issue a final opinion.

Other updates

The CHMP has recommended lifting the suspension of the marketing authorisation for Vibativ. The Committee recommended suspending the marketing authorisation for the medicine in 2012 following a Good Manufacturing Practice (GMP) inspection of Ben Venue Laboratories, Ohio, USA, which was triggered by shortcomings in quality assurance identified at this site. At its January 2014 meeting, the CHMP was of the opinion that the marketing authorisation holder has provided sufficient evidence to confirm that a suitable manufacturing site has been approved and therefore recommended lifting the suspension. The suspension of the marketing authorisation for Luminity, which was also suspended in 2012 following the same inspection, was lifted at the CHMP meeting in December 2013.

Agenda and minutes

The agenda of the January 2014 meeting is published on the EMA web site. The minutes of the meeting will be published during the week following the February CHMP meeting. Minutes of the December 2013 CHMP meeting will be published next week.

CHMP statistics

Key figures from the January 2014 CHMP meeting are included in the graphic below. We will now be providing cumulative figures in the CHMP highlights every month. 

CHMP highlights January 2014

Positive recommendations on new medicines

Name of medicineAdempas
International non-proprietary name (INN)riociguat
Marketing-authorisation applicantBayer Pharma AG
Therapeutic indicationTreatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension
More informationSummary of opinion for Adempas

 

Name of medicineEperzan
INNalbiglutide
Marketing-authorisation applicantGlaxoSmithKline Trading Services
Therapeutic indicationTreatment of type 2 diabetes mellitus
More informationSummary of opinion for Eperzan

 

Name of medicineHemoprostol
INNmisoprostol
Marketing-authorisation applicantLinepharma France
Therapeutic indicationIndicated in women of childbearing age for treatment of post-partum haemorrhage due to uterine atony in situations where intravenous oxytocin is not available
More informationSummary of opinion for Hemoprostol submitted under Article 58 for use outside the European Union

 

Name of medicineLatuda
INNlurasidone
Marketing-authorisation applicantTakeda Pharma A/S
Therapeutic indicationTreatment of schizophrenia
More informationSummary of opinion Latuda

 

Negative recommendations on new medicines

Name of medicineMasiviera
INNmasitinib
Marketing-authorisation applicantAB Science
Therapeutic indicationTreatment of non resectable locally advanced or metastatic pancreatic cancer
More informationQuestions and answers on refusal of the marketing authorisation for Masiviera

 

Name of medicineNerventra
INNlaquinimod
Marketing-authorisation applicantTeva Pharma GmbH
Therapeutic indicationTreatment of multiple sclerosis
More informationQuestions and answers on refusal of the marketing authorisation for Nerventra

 

Name of medicineReasanz
INNserelaxin
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of acute heart failure
More informationQuestions and answers on refusal of the marketing authorisation for Reasanz

 

Name of medicineTranslarna
INNataluren
Marketing-authorisation applicantPTC Therapeutics Limited
Therapeutic indicationTreatment of Duchenne muscular dystrophy
More informationQuestions and answers on refusal of the marketing authorisation for Translarna

 

Positive recommendation on new biosimilar medicine

Name of medicineBemfola
INNfollitropin alfa
Marketing-authorisation applicantFinox Biotech AG
Therapeutic indicationTreatment of infertility
More informationSummary of opinion for Bemfola

 

Positive recommendations on new generic medicines

Name of medicineRivastigmine 3M Health Care Ltd
INNrivastigmine
Marketing-authorisation applicant3M Health Care Ltd
Therapeutic indicationTreatment of Alzheimer’s dementia
More informationSummary of opinion for Rivastigmine 3M Health Care Ltd

 

Name of medicineZoledronic acid Teva Generics
INNzoledronic acid
Marketing-authorisation applicantTeva Generics B.V.
Therapeutic indicationTreatment of osteoporosis and Paget's disease of the bone
More informationSummary of opinion for Zoledronic acid Teva Generics

 

Positive recommendations on extensions of therapeutic indications 

Name of medicineNovoThirteen
INNcatridecacog
Marketing-authorisation holderNovo Nordisk A/S
More informationSummary of opinion for NovoThirteen

 

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

  

Name of medicineXolair
INNomalizumab
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Xolair

 

Outcome of harmonisation procedure

Name of medicineRocephin
INNceftriaxone
Marketing-authorisation holderRoche group of companies
More informationRocephin

 

Withdrawal of application

Name of medicineWinfuran
INNnalfurafine
Marketing-authorisation holderToray International U.K. Limited
More informationWinfuran: Withdrawn application

 

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Start of Community reviews
Scientific advice and protocol assistance
Guidelines and concept papers adopted
Organisational matters

 

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Contact point:

Monika Benstetter
Tel. +44 (0)20 7418 8427
E-mail: press@ema.europa.eu