Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015

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24/07/2015

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2015

Ten new medicines recommended for authorisation in the EU, and first malaria vaccine receives positive scientific opinion for use outside the EU

At its July meeting, the Committee for Medicinal Products for Human Use (CHMP) gave a positive scientific opinion for Mosquirix (Plasmodium falciparum and hepatitis B vaccine), the first vaccine for malaria to be assessed by a regulatory agency for use outside the European Union (EU).

Mosquirix was submitted to the European Medicines Agency (EMA) under a regulatory procedure (Article 58) that allows EMA to assess the quality, safety and efficacy of a medicine or vaccine and its benefit-risk balance, although it will not be marketed in the EU. For more information on Mosquirix and the Article 58 procedure, please see the press release and infographic in the grid below.

In addition, ten medicines were recommended for marketing authorisation in the EU. The recommendations will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation:

Praluent (alirocumab) was recommended for approval 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. For more information on Praluent, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Intuniv (guanfacine) to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years old for whom stimulants, another type of ADHD medicines, are not suitable or tolerated or have shown to be ineffective. In its scientific opinion, the CHMP stressed that Intuniv, like other medicines authorised for the treatment of ADHD, must only be used as part of a comprehensive treatment programme typically incorporating psychological, educational and social measures. The CHMP also recommended that treatment with Intuniv must be initiated under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders. For more information on Intuniv, please see the press release in the grid below.

Cresemba (isavuconazole) received a positive opinion from the CHMP for the treatment of aspergillosis and mucormycosis. Cresemba has an orphan designation.

The CHMP recommended granting a marketing authorisation for Fexeric (ferric citrate coordination complex) for the treatment of hyperphosphataemia and Obizur (susoctocog alfa) for the treatment of acquired haemophilia.

Zerbaxa (ceftolozane / tazobactam) received a positive opinion from the Committee for the treatment of complicated intra-abdominal infections, acute pyelonephritis and complicated urinary tract infections.

One hybrid medicine, Zalviso (sufentanil), received a positive opinion from the Committee for the treatment of post-operative pain. Hybrid applications rely in part on the results of studies carried out with a reference product and in part on new data.

Ivabradine Anpharm (ivabradine) was recommended for the treatment of stable chronic angina pectoris and chronic heart failure. This medicine was submitted as an informed consent application. This means that the application makes use of the data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

Two generic medicines received positive opinions from the CHMP: Pemetrexed Lilly (pemetrexed) and Pemetrexed Sandoz (pemetrexed) for the treatment of malignant pleural mesothelioma and non-small cell lung cancer.

Four recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Qutenza, Revolade, Mekinist and Tafinlar.

Request for re-examination of negative CHMP recommendation for Heparesc

The marketing authorisation holder for Heparesc has requested a re-examination of the CHMP’s June 2015 negative opinion. Upon receipt of the grounds of the request for re-examination, the CHMP will re-examine its opinion and issue a final recommendation.

Start of review

The CHMP has started a review of Inductos, an implant kit used in patients with spinal disc problems and leg fractures. For more information, please see the start of referral document in the grid below.

Agenda and minutes

The agenda of the July 2015 meeting is published on EMA’s website. The minutes of the meeting will be published during the week following the next meeting of the CHMP which will take place from 21-24 September 2015. Minutes of the June 2015 CHMP meeting will be published next week.

CHMP statistics

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

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

CHMP_highlights_July_2015

Download image in PDF format

 

Positive recommendations on new medicines

Name of medicineCresemba
International non-proprietary name (INN)isavuconazole
Marketing-authorisation applicantBasilea Medical Ltd
Therapeutic indicationTreatment of aspergillosis and mucormycosis
More informationSummary of opinion for Cresemba

  

Name of medicineFexeric
INNferric citrate coordination complex
Marketing-authorisation applicantKeryx Biopharma UK Ltd
Therapeutic indicationTreatment of hyperphosphataemia
More informationSummary of opinion for Fexeric

 

Name of medicineIntuniv
INNguanfacine
Marketing-authorisation applicantShire Pharmaceuticals Ireland Ltd
Therapeutic indicationTreatment of Attention deficit hyperactivity disorder (ADHD)
More information

Summary of opinion for Intuniv
 

Press release: EMA recommends approval of treatment for attention deficit hyperactivity disorder

 

Name of medicineMosquirix
Common namep. falciparum circumsporozoite protein fused with hepatitis B surface antigen (rts), and combined with hepatitis B surface antigen(s) in the form of non-infectious virus-like particles (vlps) produced in yeast cells (saccharomyces cerevisiae) by recombinant DNA technology
Marketing-authorisation applicantGlaxoSmithKline Biologicals S.A.
Therapeutic indicationActive immunisation against malaria
More information

Summary of opinion for Mosquirix
 

Press release: First malaria vaccine receives positive scientific opinion from EMA

 

Name of medicineObizur
INNsusoctocog alfa
Marketing-authorisation applicantBaxalta Innovations GmbH
Therapeutic indicationTreatment of bleeding episodes in patients with acquired haemophilia caused by antibodies to factor VIII
More informationSummary of opinion for Obizur

 

Name of medicinePraluent
INNalirocumab
Marketing-authorisation applicantsanofi-aventis groupe
Therapeutic indicationTreatment of adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) and mixed dyslipidaemia
More information

Summary of opinion for Praluent
 

Press release: Praluent recommended for approval to lower cholesterol

 

Name of medicineZerbaxa
INNceftolozane / tazobactam
Marketing-authorisation applicantMerck Sharp & Dohme Limited
Therapeutic indicationTreatment of complicated intra-abdominal infections, acute pyelonephritis and complicated urinary tract infections
More informationSummary of opinion for Zerbaxa


Positive recommendation on new informed-consent application

Name of medicineIvabradine Anpharm
INNivabradine
Marketing-authorisation applicantAnpharm Przedsiebiorstwo Farmaceutyczne S.A.
Therapeutic indicationTreatment of stable chronic angina pectoris and chronic heart failure
More informationSummary of opinion for Ivabradine Anpharm



Positive recommendations on new generic medicines

Name of medicinePemetrexed Lilly
INNpemetrexed
Marketing-authorisation applicantEli Lilly Netherlands
Therapeutic indicationTreatment of malignant pleural mesothelioma and non-small cell lung cancer
More informationSummary of opinion for Pemetrexed Lilly

  

Name of medicinePemetrexed Sandoz
INNpemetrexed
Marketing-authorisation applicantSandoz GmbH
Therapeutic indicationTreatment of malignant pleural mesothelioma and non-small cell lung cancer
More informationSummary of opinion for Pemetrexed Sandoz

 

Positive recommentation on new hybrid medicine

Name of medicineZalviso
INNsufentanil
Marketing-authorisation applicantGrunenthal GmbH
Therapeutic indicationTreatment of post-operative pain
More informationSummary of opinion for Zalviso


Positive recommendations on new therapeutic indications

Name of medicineMekinist
INNtrametinib
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Mekinist

 

Name of medicineQutenza
INNcapsaicin
Marketing-authorisation holderAstellas Pharma Europe BV
More informationSummary of opinion for Qutenza

 

Name of medicineRevolade
INNeltrombopag / eltrombopag olamine
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Revolade

 

Name of medicineTafinlar
INNdabrafenib
Marketing-authorisation holderNovartis Europharm Ltd
More informationSummary of opinion for Tafinlar

 

Start of referral procedure 

Name of medicineInductos
INNdibotermin alfa
Marketing-authorisation holderMedtronic BioPharma B.V.
More informationStart of referral

 

Other updates

Start of Community reviews
Scientific advice and protocol assistance
Overview of invented names reviewed in July 2015 by the Name Review Group (NRG)
Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
Opinions on safety variations
Guidelines and concept papers adopted
Organisational matters

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Article 58

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