Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 2019

News 26/07/2019

Five new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its July 2019 meeting.

The Committee recommended granting a conditional marketing authorisation for Vitrakvi* (larotrectinib), the first ‘histology-independent’ treatment in the European Union for solid tumours with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. NTRK gene fusions occur very frequently in a number of rare cancers. For more information, please see the press release in the grid below.

The CHMP granted a positive opinion for Epidyolex* (cannabidiol) for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, two forms of epilepsy. Epidyolex contains an active substance derived from cannabis and is the first to receive a positive opinion in the EU centralised procedure.

Inbrija (levodopa) received a positive opinion for the treatment of symptoms of ‘off’ periods in Parkinson’s disease.

The Committee adopted a positive opinion for Trogarzo (ibalizumab), for the treatment of HIV infection.

The CHMP recommended for approval the generic medicine Deferasirox Mylan (deferasirox), for the treatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia major, non-transfusion-dependent thalassaemia syndromes and other anaemias.

Start of re-examination of recommendation for new medicine

The applicant for Evenity (romosozumab) has requested a re-examination of the Committee's negative opinion for this medicine adopted at the June 2019 meeting. The CHMP will re-examine the opinion and issue a final recommendation. For more information on this negative opinion, please see the question-and-answer document in the grid below.

Eight recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Empliciti, Keytruda, Lonsurf, Lucentis, Soliris, Stelara, Tecentriq and Zerbaxa.

Start of re-examination of recommendations on extension of therapeutic indications

The applicants for Revolade (eltrombopag) and Translarna (ataluren) have requested re-examination of the Committee's negative opinions for these medicines adopted at the June 2019 meeting. The CHMP will re-examine the opinions and issue final recommendations. For more information on these negative opinions, please see the question-and-answer documents in the grid below.

Updated restrictions for Gilenya

The CHMP recommended that the multiple sclerosis medicine Gilenya (fingolimod) must not be used in pregnant women and in women able to have children who are not using effective contraception. If a woman becomes pregnant while using Gilenya, the medicine must be stopped and the pregnancy will have to be closely monitored. This is because the active substance in Gilenya, fingolimod, can harm the unborn baby and may cause birth defects. For more information, please see the public health recommendation in the grid below.

Agenda and minutes

The agenda of the July 2019 meeting is published on EMA's website. Minutes of the June 2019 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the July 2019 CHMP meeting are represented in the graphic below.

*This product was designated as an orphan medicine during its development. Orphan designations are reviewed by EMA's Committee for Orphan Medicinal Products (COMP) at the time of approval to determine whether the information available to date allows maintaining the medicine's orphan status and granting the medicine ten years of market exclusivity.

Positive recommendations on new medicines

Name of medicineEpidyolex
INNcannabidiol
Marketing-authorisation applicantGW Pharma (International) B.V.
Therapeutic indicationTreatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
More informationEpidyolex: Pending EC decision

 

Name of medicineInbrija 
INNlevodopa
Marketing-authorisation applicantAcorda Therapeutics Ireland Limited
Therapeutic indicationTreatment of symptoms of off periods in Parkinson’s disease
More informationInbrija: Pending EC decision 

 

Name of medicineTrogarzo
INNibalizumab
Marketing-authorisation applicantTheratechnologies International Limited
Therapeutic indicationTreatment of HIV infection
More informationTrogarzo: Pending EC decision

 

Name of medicineVitrakvi
INNlarotrectinib
Marketing-authorisation applicantBayer AG
Therapeutic indicationTreatment of patients with solid tumours that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
More informationVitrakvi: Pending EC decision
Press releaseFirst ‘histology-independent’ treatment for solid tumours with a specific gene mutation

 

Positive recommendation on new generic medicine

Name of medicineDeferasirox Mylan 
International non-proprietary name (INN)deferasirox 
Marketing-authorisation applicantMylan S.A.S.
Therapeutic indicationTreatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia major, non-transfusion-dependent thalassaemia syndromes and other anaemias
More informationDeferasirox Mylan: Pending EC decision

 

Start of re-examination of recommendation for new medicine

Name of medicineEvenity
INNromosozumab
Marketing-authorisation applicantUCB Pharma S.A. 
Therapeutic indicationTreatment of osteoporosis
More informationEvenity: Pending EC decision 

 

Positive recommendations on extensions of indications

Name of medicineEmpliciti
INNelotuzumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationEmpliciti: Pending EC decision 

 

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holderMerck Sharp & Dohme B.V.
More informationKeytruda: Pending EC decision

 

Name of medicineLonsurf
INNtrifluridine / tipiracil 
Marketing-authorisation holderLes Laboratoires Servier
More informationLonsurf: Pending EC decision

 

Name of medicineLucentis
INNranibizumab
Marketing-authorisation holderNovartis Europharm Limited
More informationLucentis: Pending EC decision 

 

Name of medicineSoliris
INNeculizumab
Marketing-authorisation holderAlexion Europe SAS
More informationSoliris: Pending EC decision

 

Name of medicineStelara
INNustekinumab
Marketing-authorisation holderJanssen-Cilag International NV
More informationStelara: Pending EC decision

 

Name of medicineTecentriq
INNatezolizumab
Marketing-authorisation holderRoche Registration GmbH
More informationTecentriq: Pending EC decision

 

Name of medicineZerbaxa
INNceftolozane / tazobactam
Marketing-authorisation holder

Merck Sharp & Dohme B.V.

More informationZerbaxa: Pending EC decision

 

Start of re-examination of extension of indication

Name of medicineRevolade
INNeltrombopag
Marketing-authorisation holderNovartis Europharm Limited
More informationRevolade: Pending EC decision

 

Name of medicineTranslarna
INNataluren
Marketing-authorisation holderPTC Therapeutics International Limited
More informationTranslarna: Pending EC decision

 

Public-health recommendation

How useful was this page?

Add your rating
Average
2 ratings
1 rating