Meeting highlights from the Committee for Medicinal Products for Human Use


Meeting highlights from the Committee for Medicinal Products for Human Use

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.



Name of medicine
Qtrilmet
INN
metformin hydrochloride / saxagliptin / dapagliflozin
Marketing-authorisation applicant
AstraZeneca AB
Therapeutic indication
Treatment of type 2 diabetes mellitus
More information
Qtrilmet: Pending EC decision

Name of medicine
Rhokiinsa
INN
netarsudil
Marketing-authorisation applicant
Aerie Pharmaceuticals Ireland Ltd
Therapeutic indication
Treatment of patients with glaucoma or ocular hypertension
More information
Rhoki`insa: Pending EC decision

Name of medicine
Xospata
INN
gilteritinib
Marketing-authorisation applicant
Astellas Pharma Europe B.V.
Therapeutic indication
Treatment of adult patients who have relapsed or refractory acute myeloid leukaemia with a FLT3 mutation
More information

Positive recommendation on new informed consent medicine
Name of medicine
Senstend
INN
lidocaine / prilocaine 
Marketing-authorisation applicant
Plethora Pharma Solutions Limited
Therapeutic indication
Treatment of premature ejaculation in adult men
More information
Senstend: Pending EC decision

Positive recommendations on new generic medicines
Name of medicine
Arsenic trioxide Accord

arsenic trioxide
Marketing-authorisation applicant
Accord Healthcare S.L.U.
Therapeutic indication
Treatment of acute promyelocytic leukaemia
More information
Arsenic trioxide Accord: Pending EC decision

Name of medicine
Bortezomib Fresenius Kabi 
bortezomib
Marketing-authorisation applicant
Fresenius Kabi Deutschland GmbH
Therapeutic indication
Treatment of multiple myeloma and mantle cell lymphoma
More information
Bortezomib Fresenius Kabi: Pending EC decision

Name of medicine
Ivozall 
clofarabine
Marketing-authorisation applicant
ORPHELIA Pharma SAS
Therapeutic indication
Treatment of acute lymphoblastic leukaemia in paediatric patients
More information

Positive recommendations on extensions of indications
Name of medicine
Bavencio
INN
Avelumab
Marketing-authorisation applicant
Merck Europe B.V.
More information

Name of medicine
Benlysta
INN
belimumab
Marketing-authorisation applicant
GlaxoSmithKline (Ireland) Limited
More information

Name of medicine
Docetaxel Zentiva 
INN
Docetaxel
Marketing-authorisation applicant
Zentiva, k.s.
More information
Docetaxel Zentiva (previously Docetaxel Winthrop): Pending EC decision

Name of medicine
Dupixent
INN
dupilumab
Marketing-authorisation applicant
Sanofi-Aventis Groupe
More information
Dupixent: Pending EC decision

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

Name of medicine
Remisima
INN
Infliximab
Marketing-authorisation applicant
Celltrion Healthcare Hungary Kft.
More information
Remsima: Pending EC decision

Name of medicine
Taxotere
INN
Docetaxel
Marketing-authorisation applicant
Aventis Pharma S.A.
More information
Taxotere: Pending EC decision

Name of medicine
Trulicity
INN
dulaglutide
Marketing-authorisation applicant
Eli Lilly Nederland B.V.
More information
Trulicity: Pending EC decision






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