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

 

London, UK (April 1, 2016) – 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.jpg 

 

 

 

 

Positive recommendations on new medicines

 

 

Name of medicine

Darzalex

International non-proprietary name (INN)

daratumumab

Marketing-authorisation applicant

Janssen-Cilag International N.V.

Therapeutic indication

Treatment of relapsed and refractory multiple myeloma

More information

Summary of opinion for Darzalex

 

Press release: New treatment for patients with multiple myeloma

  

Name of medicine

Galafold

INN

migalastat

Marketing-authorisation applicant

Amicus Therapeutics UK Ltd

Therapeutic indication

Treatment 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 medicine

Pandemic influenza vaccine H5N1 MedImmune

INN

pandemic influenza vaccine (H5N1) (live attenuated, nasal)

Marketing-authorisation applicant

MedImmune LLC

Therapeutic indication

Prophylaxis of influenza

More information

Summary of opinion for pandemic influenza vaccine H5N1 MedImmune

 

Name of medicine

Strimvelis

INN

autologous cd34+ enriched cell fraction that contains cd34+ cells transduced with retroviral vector that encodes for the human ada cdna sequence

Marketing-authorisation applicant

GlaxoSmithKline Trading Services

Therapeutic indication

Treatment 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 medicine

Neparvis

INN

sacubitril / valsartan

Marketing-authorisation applicant

Novartis Europharm Ltd

Therapeutic indication

Treatment of chronic heart failure with reduced ejection fraction

More information

Summary of opinion for Neparvis

 

 

Positive recommendation on new generic medicine

 

Name of medicine

Palonosetron Accord

International non-proprietary name

palonosetron

Marketing-authorisation applicant

Accord Healthcare Ltd

Therapeutic indication

Prevention of nausea and vomiting associated with cancer chemotherapy

More information

Summary of opinion for Palonosetron Accord

 

 

Positive recommendation on new biosimilar medicine

 

Name of medicine

Flixabi

INN

infliximab

Marketing-authorisation applicant

Samsung Bioepis UK Limited

Therapeutic indication

Treatment of rheumatoid arthritis, adult and paediatric Crohn’s disease, ulcerative colitis, paediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis

More information

Summary of opinion for Flixabi

 

 

Re-examination of recommendation for new medicine

 

Name of medicine

Dropcys

International non-proprietary name (INN)

mercaptamine

Marketing-authorisation applicant

Lucane Pharma

Therapeutic indication

Treatment of corneal cystine deposits

More information

Questions and answers on refusal of marketing authorisation for Dropcys

 

 

Positive recommendations on extensions of therapeutic indications    

 

Name of medicine

Halaven

INN

eribulin

Marketing-authorisation holder

Eisai Europe Ltd

More information

Summary of opinion for Halaven

 

Name of medicine

Humira

INN

adalimumab

Marketing-authorisation holder

AbbVie Ltd

More information

Summary of opinion for Humira

     

Name of medicine

Opdivo

INN

nivolumab

Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

More information

Summary of opinion for Opdivo

 

 

Other procedures

 

Name of medicine

Trevicta (previously known as Paliperidone Janssen)

INN

paliperidone

Marketing-authorisation holder

Janssen-Cilag International NV

More information

Summary of opinion for Trevicta (previously known as Paliperidone Janssen)

 

 

Starts of referrals

 

Name of medicine

Alkem – Article-31

Marketing-authorisation holder

Alkem Laboratories Ltd (India)

More information

Alkem

  

Name of medicine

Symbioflor 2 – Article-31

INN

Escherichia coli bacteria (cells and autolysate)

More information

Symbioflor 2

 

Name of medicine

Vancomycin-containing medicines – Article-31

INN

vancomycin

More information

Vancomycin-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

Opinions on consultation procedures on ancillary medicinal substances in medical devices

 


European Medicines Agency (EMA), 01.04.2016 (tB).

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