Meeting Highlights From The Committee For Medicinal Products For ...

Skip to main contentMeeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 July 201926 July 2019NewsHumanMedicines

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 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	Epidyolex: Pending EC decision

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	Trogarzo: Pending EC decision

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	Deferasirox Mylan: Pending EC decision

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 decision

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	Lonsurf: Pending EC decision

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

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: Pending EC decision

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

Name of medicine	Gilenya
INN	fingolimod
More information	Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 22-25 July 2019

AdoptedReference Number: EMA/317956/2019

English (EN) (164.58 KB - PDF)

First published: 31/07/2019View

Scientific advice and protocol assistance adopted during the CHMP meeting 22-25 July 2019

AdoptedReference Number: EMA/CHMP/SAWP/420885/2019

English (EN) (153.65 KB - PDF)

First published: 26/07/2019View

Related information

• First ‘histology-independent’ treatment for solid tumours with a specific gene mutation
• Updated restrictions for Gilenya: multiple sclerosis medicine not to be used in pregnancy
• Committee for Medicinal Products for Human Use (CHMP): 22-25 July 2019
• CHMP: Agendas, minutes and highlights

Contact point

EMA press officeTel. +31 (0)88 781 8427E-mail: press@ema.europa.euFollow us on Twitter @EMA_News

Related content

• Epidyolex
• Inbrija
• Trogarzo
• Vitrakvi
• Deferasirox Mylan
• Evenity
• Empliciti
• Keytruda
• Lonsurf
• Lucentis
• Stelara
• Soliris
• Tecentriq
• Zerbaxa
• Translarna
• Revolade
• Gilenya

Topics

• Medicines

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