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.

CHMP highlights July 2019

Positive recommendations on new medicines

Name of medicine Epidyolex
INN cannabidiol
Marketing-authorisation applicant GW Pharma (International) B.V.
Therapeutic indication Treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome
More information

Name of medicine Inbrija 
INN levodopa
Marketing-authorisation applicant Acorda Therapeutics Ireland Limited
Therapeutic indication Treatment of symptoms of off periods in Parkinson’s disease
More information Inbrija: Pending EC decision

Name of medicine Trogarzo
INN ibalizumab
Marketing-authorisation applicant Theratechnologies International Limited
Therapeutic indication Treatment of HIV infection
More information

Name of medicine Vitrakvi
INN larotrectinib
Marketing-authorisation applicant Bayer AG
Therapeutic indication Treatment of patients with solid tumours that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion
More information Vitrakvi: Pending EC decision
Press release First ‘histology-independent’ treatment for solid tumours with a specific gene mutation

Positive recommendation on new generic medicine

Name of medicine Deferasirox Mylan 
International non-proprietary name (INN) deferasirox 
Marketing-authorisation applicant Mylan S.A.S.
Therapeutic indication Treatment of chronic iron overload due to blood transfusions in patients with beta thalassaemia major, non-transfusion-dependent thalassaemia syndromes and other anaemias
More information

Start of re-examination of recommendation for new medicine

Name of medicine Evenity
INN romosozumab
Marketing-authorisation applicant UCB Pharma S.A. 
Therapeutic indication Treatment of osteoporosis
More information Evenity: Pending EC decision

Positive recommendations on extensions of indications

Name of medicine Empliciti
INN elotuzumab
Marketing-authorisation holder Bristol-Myers Squibb Pharma EEIG
More information Empliciti: Pending EC

Name of medicine Keytruda
INN pembrolizumab
Marketing-authorisation holder Merck Sharp & Dohme B.V.
More information Keytruda: Pending EC decision

Name of medicine Lonsurf
INN trifluridine / tipiracil 
Marketing-authorisation holder Les Laboratoires Servier
More information

Name of medicine Lucentis
INN ranibizumab
Marketing-authorisation holder Novartis Europharm Limited
More information

Name of medicine Soliris
INN eculizumab
Marketing-authorisation holder Alexion Europe SAS
More information Soliris: Pending EC decision

Name of medicine Stelara
INN ustekinumab
Marketing-authorisation holder Janssen-Cilag International NV
More information Stelara: Pending EC decision

Name of medicine Tecentriq
INN atezolizumab
Marketing-authorisation holder Roche Registration GmbH
More information Tecentriq: Pending EC decision

Name of medicine Zerbaxa
INN ceftolozane / tazobactam
Marketing-authorisation holder

Merck Sharp & Dohme B.V.

More information Zerbaxa

Start of re-examination of extension of indication

Name of medicine Revolade
INN eltrombopag
Marketing-authorisation holder Novartis Europharm Limited
More information Revolade: Pending EC decision

Name of medicine Translarna
INN ataluren
Marketing-authorisation holder PTC Therapeutics International Limited
More information Translarna: Pending EC decision

Public-health recommendation

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