Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2018

News 14/12/2018

EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its December 2018 meeting.

Two orphan medicines1 received a positive opinion from the Committee: Besremi (ropeginterferon alfa-2b), for the treatment of polycythaemia vera without symptomatic splenomegaly, and Trecondi (treosulfan), for the conditioning treatment prior to allogeneic haematopoietic stem cell transplantation.

The CHMP recommended granting a marketing authorisation for Lusutrombopag Shionogi (lusutrombopag), for the treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.

Rizmoic (naldemedine) received a positive opinion for the treatment of opioid-induced constipation.

The Committee granted a positive opinion for Tobramycin PARI (tobramycin), a hybrid medicine for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged six years and older with cystic fibrosis. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of a reference product and in part on new data.

The biosimilar medicine Zirabev (bevacizumab) received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer and carcinoma of the cervix.

The Committee recommended for approval the generic medicine Miglustat Dipharma (miglustat), for the treatment of adult patients with mild to moderate type 1 Gaucher disease.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Adcetris, Rapiscan, Rubraca, Simponi, Sprycel and Trimbow.

Start of referral

The CHMP started a review of medicines containing the antibiotic fosfomycin, which is used in a number of EU Member States to treat a range of bacterial infections. The Committee will re-evaluate the uses and doses authorised in the light of up-to-date knowledge on antibacterial therapy. For more information, please see the start-of-referral document in the grid below.

Outcome of review on metamizole-containing medicines

The CHMP recommended that the maximum daily dose of the painkiller metamizole and the contraindications to its use in pregnancy or in women who are breastfeeding should be harmonised for all products on the EU market. Metamizole medicines are marketed in many EU Member States to treat severe pain and fever that cannot be controlled with other treatments. For more information, please see the public health recommendation in the grid below.

Outcome of review on omega-3 fatty acid medicines

The CHMP concluded that omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems in patients who have had a heart attack. The conclusion, based on a review of data accumulated over the years, means that these medicines will no longer be authorised for such use. For more information, please see the public health recommendation in the grid below.

Status of review of impurities in sartan medicines

The review of the blood pressure medicines containing candesartan, irbesartan, losartan, olmesartan or valsartan in relation to impurities found in some batches is still ongoing. A new timetable for the finalisation of the review will be published shortly.

Withdrawals of applications

Applications for initial marketing authorisations for Fyzoclad (adalimumab) and canakinumab Novartis (canakinumab) have been withdrawn. Fyzoclad was intended to be used to treat a number of inflammatory diseases. Canakinumab Novartis was intended to be used to prevent serious events such as stroke, heart attack or death in patients who have had a heart attack.

Question-and-answer documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the December 2018 meeting is published on EMA's website. Minutes of the November 2018 CHMP meeting will be published in the coming weeks.


 1 As always at time of approval, these orphan designations will now be reviewed by EMA's Committee for Orphan Medicinal Products (COMP) to determine whether the information available to date allows maintaining the medicines’ orphan status and granting the medicines ten years of market exclusivity.

 

CHMP statistics

Key figures from the December 2018 CHMP meeting are represented in the graphic below.

CHMP statistics: December 2018

Positive recommendations on new medicines

Name of medicineBesremi
International non-proprietary name (INN)ropeginterferon alfa-2b
Marketing-authorisation applicantAOP Orphan Pharmaceuticals AG
Therapeutic indication

Treatment of polycythaemia vera without symptomatic splenomegaly.

 

Name of medicineLusutrombopag Shionogi
INNlusutrombopag
Marketing-authorisation applicantShionogi B.V.
Therapeutic indication

Treatment of severe thrombocytopenia in adults with chronic liver disease undergoing invasive procedures.

 

Name of medicineRizmoic
INNnaldemedine
Marketing-authorisation applicantShionogi B.V.
Therapeutic indication

Treatment of opioid-induced constipation.

 

Name of medicineTrecondi
INNtreosulfan
Marketing-authorisation applicantmedac Gesellschaft fur klinische Spezialpraparate mbH
Therapeutic indication

Conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT)

Positive recommendation on new hybrid medicine

Name of medicineTobramycin PARI
INNtobramycin
Marketing-authorisation applicantPARI Pharma Gmb
Therapeutic indication

Management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis.

Positive recommendation on new biosimilar medicine

Name of medicineZirabev
INNbevacizumab
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indication

Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer and carcinoma of the cervix.

Positive recommendations on new generic medicine

Name of medicineMiglustat Dipharma 
INNmiglustat
Marketing-authorisation applicantDipharma B.V.
Therapeutic indication

Treatment of adult patients with mild to moderate type 1 Gaucher disease.

Positive recommendations on extensions of indications

Name of medicineAdcetris 
INNbrentuximab vedotin 
Marketing-authorisation holderTakeda Pharma A/S

 

Name of medicineRapiscan
INNregadenoson
Marketing-authorisation holderGE Healthcare AS

 

Name of medicineRubraca
INNrucaparib
Marketing-authorisation holderClovis Oncology UK Limited

 

Name of medicineSimponi
INNgolimumab
Marketing-authorisation holderJanssen Biologics B.V.

 

Name of medicineSprycel
INNdasatinib
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG

 

Name of medicineTrimbow
INNbeclometasone dipropionate / formoterol fumarate dihydrate / glycopyrronium
Marketing-authorisation holderChiesi Farmaceutici S.p.A.

Start of referral

Name of medicineFosfomycin containing medicinal products 
INNfosfomycin calcium, fosfomycin disodium, fosfomycin sodium, fosfomycin trometamol
More informationEMA begins review of medicines containing fosfomycin

Public-health recommendations

 

Name of medicineOmega-3 fatty acid medicines
INNOmega-3 fatty acid medicines
More informationOmega-3 fatty acid medicines no longer considered effective in preventing heart disease

Withdrawal of initial marketing authorisation applications

Name of medicineFyzoclad
INNadalimumab
Marketing-authorisation applicantPfizer Europe MA EEIG
More information 

 

Name of medicineCanakinumab Novartis
INNcanakinumab
Marketing-authorisation applicantNovartis Europharm Limited
More information 

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