Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 29 March - 1 April 2016

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01/04/2016

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 29 March - 1 April 2016

Seven new medicines, including one advanced therapy, recommended for approval

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines, including one advanced therapy medicinal product (ATMP), for approval at its March meeting.

The CHMP recommendedgranting a marketing authorisation for Strimvelis, a new gene therapy intended for the treatment of patients with adenosine-deaminase-deficient severe combined immunodeficiency (ADA-SCID), who have no matching donor for a stem cell transplant. Strimvelis has an orphan designation and is an ATMP. For more information, please see the press release in the grid below.

The Committee recommended granting a conditional marketing authorisation for Darzalex (daratumumab) for the treatment of relapsed and refractory multiple myeloma. Darzalex has an orphan designation and was reviewed under EMA’s accelerated assessment scheme. For more information, please see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Galafold (migalastat) for the treatment of Fabry disease, a rare genetic disorder. Galafold has an orphan designation. For more information, please see the press release in the grid below.

Pandemic influenza vaccine H5N1 MedImmune also received a positive opinion from the CHMP. This is the first pandemic live attenuated influenza vaccine against avian influenza (H5N1) to be recommended for approval in the European Union (EU). The vaccine is intended for pandemic preparedness.

A biosimilarmonoclonal antibody, Flixabi (infliximab), was granted a positive opinion by the Committee for the treatment of rheumatoid arthritis, adult and paediatric Crohn's disease, ulcerative colitis, paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

The CHMP also granted a positive opinion for the informed consent application Neparvis (sacubitril / valsartan) for the treatment of chronic heart failure with reduced ejection fraction. In an informed consent application, reference is made to an authorised medicine and the marketing authorisation holder of the reference medicine has given consent to the use of their dossier in the application procedure. The reference product for Neparvis is Entresto.

A generic medicine, Palonosetron Accord (palonosetron), received a positive opinion from the Committee for the prevention of nausea and vomiting associated with chemotherapy.

Three recommendations on extensions of therapeutic indications

The Committee recommended extensions of indications for Halaven, Humira and Opdivo.

Re-examination procedure concluded

The CHMP concluded a re-examination procedure, issuing a final negative opinion for Dropcys (mercaptamine). A questions-and-answers document on this opinion is available below.

Review on vancomycin

The CHMP started a review of medicines containing the antibiotic vancomycin as part of its efforts to update product information of older antibacterial agents in the context of the fight against antimicrobial resistance. The revision of product information for critically important antibiotics is considered an important way of promoting appropriate use to ensure they remain available to EU patients. For more information, please see the start of referral documents in the grid below.

Review on Symbioflor 2

The Committee started a review of the medicine Symbioflor 2 (Escherichia coli bacteria), which is authorised in some Member States of the EU for treating diseases affecting the stomach and gut including irritable bowel syndrome.For more information, please see the start of referral documents in the grid below.

Review of medicines for which studies have been conducted at Alkem BE, India

The CHMP also started a review of medicinesfor which studies have been conducted at the Alkem BE site in Mumbai, India. This follows a good clinical practice (GCP) inspection of this site which raised concerns regarding study data used to support the marketing authorisation applications of some medicines in the EU. For more information, please see the start of referral documents in the grid below.

Agenda and minutes

The agenda of the March 2016 meeting is published on EMA’s website. Minutes of the February 2016 CHMP meeting will be published next week.

CHMP statistics

Key figures from the March 2016 CHMP meeting are represented in the graphic below.

More information on this, and all other outcomes of the CHMP’s March 2016 meeting, is available in the grid below.

CHMP_highlights_March_2016

Download image in PDF format

Positive recommendations on new medicines

Name of medicineDarzalex
International non-proprietary name (INN)daratumumab
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationTreatment of relapsed and refractory multiple myeloma
More information

Summary of opinion for Darzalex

 

Press release: New treatment for patients with multiple myeloma

  

Name of medicineGalafold
INNmigalastat
Marketing-authorisation applicantAmicus Therapeutics UK Ltd
Therapeutic indicationTreatment of Fabry disease
More information

Summary of opinion for Galafold

 

Press release: First oral treatment for Fabry disease recommended for approval in the EU

  

Name of medicinePandemic influenza vaccine H5N1 MedImmune
INNpandemic influenza vaccine (H5N1) (live attenuated, nasal)
Marketing-authorisation applicantMedImmune LLC
Therapeutic indicationProphylaxis of influenza
More informationSummary of opinion for pandemic influenza vaccine H5N1 MedImmune

 

Name of medicineStrimvelis
INNautologous cd34+ enriched cell fraction that contains cd34+ cells transduced with retroviral vector that encodes for the human ada cdna sequence
Marketing-authorisation applicantGlaxoSmithKline Trading Services
Therapeutic indicationTreatment of severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID)
More information

Summary of opinion for Strimvelis

 

Press release: New gene therapy for the treatment of children with ultra-rare immune disorder recommended for approval

   

Positive recommendation on new informed-consent application

Name of medicineNeparvis
INNsacubitril / valsartan
Marketing-authorisation applicantNovartis Europharm Ltd
Therapeutic indicationTreatment of chronic heart failure with reduced ejection fraction
More informationSummary of opinion for Neparvis

 

Positive recommendation on new generic medicine

Name of medicinePalonosetron Accord
International non-proprietary namepalonosetron
Marketing-authorisation applicantAccord Healthcare Ltd
Therapeutic indicationPrevention of nausea and vomiting associated with cancer chemotherapy
More informationSummary of opinion for Palonosetron Accord

 

Positive recommendation on new biosimilar medicine

Name of medicineFlixabi
INNinfliximab
Marketing-authorisation applicantSamsung Bioepis UK Limited
Therapeutic indicationTreatment of rheumatoid arthritis, adult and paediatric Crohn's disease, ulcerative colitis, paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis
More informationSummary of opinion for Flixabi

 

Re-examination of recommendation for new medicine

Name of medicineDropcys
International non-proprietary name (INN)mercaptamine
Marketing-authorisation applicantLucane Pharma
Therapeutic indicationTreatment of corneal cystine deposits
More informationQuestions and answers on refusal of marketing authorisation for Dropcys

 

Positive recommendations on extensions of therapeutic indications    

Name of medicineHalaven
INNeribulin
Marketing-authorisation holderEisai Europe Ltd
More informationSummary of opinion for Halaven

 

Name of medicineHumira
INNadalimumab
Marketing-authorisation holderAbbVie Ltd
More informationSummary of opinion for Humira

     

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationSummary of opinion for Opdivo

 

Other procedures

Name of medicineTrevicta (previously known as Paliperidone Janssen)
INNpaliperidone
Marketing-authorisation holderJanssen-Cilag International NV
More informationSummary of opinion for Trevicta (previously known as Paliperidone Janssen)

 

Starts of referrals

Name of medicineAlkem - Article-31
Marketing-authorisation holderAlkem Laboratories Ltd (India)
More informationAlkem

  

Name of medicineSymbioflor 2 - Article-31
INNEscherichia coli bacteria (cells and autolysate)
More informationSymbioflor 2

 

Name of medicineVancomycin-containing medicines - Article-31
INNvancomycin
More informationVancomycin-containing medicines

  

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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