Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019

News 20/09/2019

Seven new medicines recommended for approval

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

The Committee recommended granting a marketing authorisation for Xospata* (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. AML is a rare type of cancer of the white blood cells (cells that fight infections). It affects approximately 1 in 10,000 people in the European Union. Xospata was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest.

Qtrilmet (metformin hydrochloride / saxagliptin / dapagliflozin) received a positive opinion from the CHMP for the treatment of type 2 diabetes mellitus.

The CHMP recommended granting a marketing authorisation for Rhokiinsa (netarsudil) for the treatment of patients with glaucoma or ocular hypertension.

Senstend (lidocaine / prilocaine), which was evaluated in an informed consent application, received a positive opinion for the treatment of premature ejaculation in adult men. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

The CHMP recommended granting marketing authorisations for three generic medicines: Arsenic trioxide Accord (arsenic trioxide), for the treatment of acute promyelocytic leukaemia; Bortezomib Fresenius Kabi (bortezomib), for the treatment of multiple myeloma and mantle cell lymphoma; and Ivozall (clofarabine), for the treatment of acute lymphoblastic leukaemia in paediatric patients.

Eight recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Bavencio, Benlysta, Docetaxel Zentiva, Dupixent, Lucentis, Remisima, Taxotere and Trulicity.

Agenda and minutes

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

CHMP statistics

Key figures from the September 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 September 2019

Positive recommendations on new medicines

Name of medicineQtrilmet
INNmetformin hydrochloride / saxagliptin / dapagliflozin
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of type 2 diabetes mellitus
More informationQtrilmet: Pending EC decision

 

Name of medicineRhokiinsa
INNnetarsudil
Marketing-authorisation applicantAerie Pharmaceuticals Ireland Ltd
Therapeutic indicationTreatment of patients with glaucoma or ocular hypertension
More informationRhokiinsa: Pending EC decision

 

Name of medicineXospata
INNgilteritinib
Marketing-authorisation applicantAstellas Pharma Europe B.V.
Therapeutic indicationTreatment of adult patients who have relapsed or refractory acute myeloid leukaemia with a FLT3 mutation
More informationXospata: Pending EC decision

 

Positive recommendation on new informed consent medicine

Name of medicineSenstend
INNlidocaine / prilocaine 
Marketing-authorisation applicantPlethora Pharma Solutions Limited
Therapeutic indicationTreatment of premature ejaculation in adult men
More informationSenstend: Pending EC decision

 

Positive recommendations on new generic medicines

Name of medicineArsenic trioxide Accord
International non-proprietary name (INN)
arsenic trioxide
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of acute promyelocytic leukaemia
More informationArsenic trioxide Accord: Pending EC decision

 

Name of medicineBortezomib Fresenius Kabi 
International non-proprietary name (INN)bortezomib
Marketing-authorisation applicantFresenius Kabi Deutschland GmbH
Therapeutic indicationTreatment of multiple myeloma and mantle cell lymphoma
More informationBortezomib Fresenius Kabi: Pending EC decision

 

Name of medicineIvozall 
International non-proprietary name (INN)clofarabine
Marketing-authorisation applicantORPHELIA Pharma SAS
Therapeutic indicationTreatment of acute lymphoblastic leukaemia in paediatric patients
More informationIvozall: Pending EC decision

 

Positive recommendations on extensions of indications

Name of medicineBavencio
INNavelumab
Marketing-authorisation applicantMerck Europe B.V.
More informationBavencio: Pending EC decision

 

Name of medicineBenlysta
INNbelimumab
Marketing-authorisation applicantGlaxoSmithKline (Ireland) Limited
More informationBenlysta: Pending EC decision

 

Name of medicineDocetaxel Zentiva 
INNdocetaxel
Marketing-authorisation applicantZentiva, k.s.
More informationDocetaxel Zentiva (previously Docetaxel Winthrop): Pending EC decision

 

Name of medicineDupixent
INNdupilumab
Marketing-authorisation applicantSanofi-Aventis Groupe
More informationDupixent: Pending EC decision

 

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

 

Name of medicineRemisima
INNinfliximab
Marketing-authorisation applicantCelltrion Healthcare Hungary Kft.
More informationRemsima: Pending EC decision

 

Name of medicineTaxotere
INNdocetaxel
Marketing-authorisation applicantAventis Pharma S.A.
More informationTaxotere: Pending EC decision

 

Name of medicineTrulicity
INNdulaglutide
Marketing-authorisation applicantEli Lilly Nederland B.V.
More informationTrulicity: Pending EC decision

 

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