Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023

31 March 2023

Nine new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting.

The CHMP recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and older who have previously been vaccinated with a mRNA COVID-19 vaccine. It is the eighth vaccine recommended in the European Union (EU) for protecting against COVID-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic. An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website. See more information in the news announcement in the grid below.

The committee adopted a positive opinion for Briumvi (ublituximab) for the treatment of relapsing multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and the nerve themselves.

Omvoh (mirikizumab) received a positive opinion from the CHMP for the treatment of moderately to severely active ulcerative colitis, an inflammation of the large intestine causing ulceration and bleeding.

The committee recommended granting a paediatric-use marketing authorisation (PUMA) for Pedmarqsi (sodium thiosulfate) for the prevention of ototoxicity induced by cisplatin chemotherapy. Ototoxicity is the development of hearing or balance problems due to a medicine and Cisplatin is a chemotherapy used to treat several types of cancer. Pedmarqsi is indicated in patients from one month up to 18 years of age with localised, non-metastatic, solid tumours.

The committee adopted a positive opinion for Epysqli (eculizumab), a biosimilar medicine for the treatment of paroxysmal nocturnal haemoglobinuria, a rare disorder that leads to the premature destruction and impaired production of blood cells.

The CHMP gave a positive opinion to Qaialdo (spironolactone) for the management of refractory oedema, a persistent swelling which does not respond to the use of diuretics and sodium restriction. This medicine was submitted as a hybrid application, which relies in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

The committee adopted positive opinions for three generic medicines:

• Dabigatran Etexilate Accord (dabigatran etexilate) for the prevention of venous thromboembolic events;
• Lacosamide Adroiq (lacosamide) for the treatment of epilepsy;
• Sugammadex Adroiq (sugammadex) for the reversal of neuromuscular blockade induced by rocuronium or vecuronium.

Recommendations on extensions of therapeutic indication for six medicines

The committee recommended six extensions of indication for medicines that are already authorised in the EU: Breyanzi, Entresto and its duplicate Neparvis, Tenkasi, Ultomiris and Wegovy.

For Ultomiris, the committee also recommended a new route of administration with a new strength and pharmaceutical form.

Withdrawals of applications

Three applications for marketing authorisation were withdrawn: 

• Feraheme, intendedfor the intravenous treatment of iron deficiency anaemia.
• Onteeo, intendedfor the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, and COVID-19.
• Raltegravir Viatris, intended for the treatment of human immunodeficiency virus (HIV-1) infection.

Question-and-answer documents on the withdrawals of Feraheme and Raltegravir Viatris are available in the grid below. Onteeo is a duplicate of a medicine which is currently under evaluation.

Agenda and minutes

The Agenda of the CHMP meeting 27-30 March 2023 of the March 2023 CHMP meeting is published on EMA's website. Minutes of the February 2023 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the March 2023 CHMP meeting are represented in the graphic below.

 

Positive recommendations on new medicines

Name of medicine	Bimervax
Common name	COVID-19 vaccine
Marketing-authorisation applicant	Hipra Human Health SLU
Therapeutic indication	Immunisation to prevent COVID-19 caused by SARS-CoV-2
More information	Bimervax: Pending EC decision News: EMA recommends approval of Bimervax as a COVID-19 booster vaccine

 

Name of medicine	Briumvi
INN	ublituximab
Marketing-authorisation applicant	Propharma Group The Netherlands B.V.
Therapeutic indication	Treatment of relapsing forms of multiple sclerosis (RMS) (new active substance)
More information	Briumvi: Pending EC decision

 

Name of medicine	Omvoh
INN	mirikizumab
Marketing-authorisation applicant	Eli Lilly Nederland B.V.
Therapeutic indication	Treatment of moderately to severely active ulcerative colitis (new active substance)
More information	Omvoh: Pending EC decision

 

Name of medicine	Pedmarqsi
INN	sodium thiosulfate
Marketing-authorisation applicant	Fennec Pharmaceuticals (EU) Limited
Therapeutic indication	For the prevention of ototoxicity induced by cisplatin (CIS) chemotherapy in patients 1 month to < 18 years of age with localized, non-metastatic, solid tumours (known active substance)
More information	Pedmarqsi: Pending EC decision

 

Positive recommendation on new biosimilar medicine

Name of medicine	Epysqli
INN	eculizumab
Marketing-authorisation applicant	Samsung Bioepis NL B.V.
Therapeutic indication	Treatment of paroxysmal nocturnal haemoglobinuria
More information	Epysqli: Pending EC decision

 

Positive recommendation on new hybrid medicine

Name of medicine	Qaialdo
INN	spironolactone
Marketing-authorisation applicant	Nova Laboratories Ireland Limited
Therapeutic indication	Management of refractory oedema
More information	Qaialdo: Pending EC decision

 

Positive recommendation on new generic medicines

Name of medicine	Dabigatran Etexilate Accord
INN	dabigatran etexilate
Marketing-authorisation applicant	Accord Healthcare S.L.U.
Therapeutic indication	Prevention of venous thromboembolic events
More information	Dabigatran Etexilate Accord: Pending EC decision

 

Name of medicine	Lacosamide Adroiq
INN	lacosamide
Marketing-authorisation applicant	Extrovis EU Ltd.
Therapeutic indication	Treatment of epilepsy
More information	Lacosamide Adroiq: Pending EC decision

 

Name of medicine	Sugammadex Adroiq
INN	sugammadex
Marketing-authorisation applicant	Extrovis EU Ltd.
Therapeutic indication	Reversal of neuromuscular blockade induced by rocuronium or vecuronium
More information	Sugammadex Adroiq: Pending EC decision

 

Positive recommendations on extensions of indications

Name of medicine	Breyanzi
INN	lisocabtagene maraleucel / lisocabtagene maraleucel
Marketing-authorisation holder	Bristol-Myers Squibb Pharma EEIG
More information	Breyanzi: Pending EC decision

 

Name of medicine	Entresto
INN	sacubitril / valsartan
Marketing-authorisation holder	Novartis Europharm Limited
More information	Entresto: Pending EC decision

 

Name of medicine	Neparvis
INN	sacubitril / valsartan
Marketing-authorisation holder	Novartis Europharm Limited
More information	Neparvis : Pending EC decision

 

Name of medicine	Tenkasi
INN	oritavancin
Marketing-authorisation holder	Menarini International Operations Luxembourg S.A.
More information	Tenkasi: Pending EC decision

 

Name of medicine	Ultomiris
INN	ravulizumab
Marketing-authorisation holder	Alexion Europe SAS
More information	Ultomiris: Pending EC decision (II-32)

 

Name of medicine	Wegovy
INN	semaglutide
Marketing-authorisation holder	Novo Nordisk A/S
More information	Wegovy: Pending EC decision

 

Recommendation on new pharmaceutical forms / strengths / routes of administration

Name of medicine	Ultomiris
INN	ravulizumab
Marketing-authorisation applicant	Alexion Europe SAS
More information	Ultomiris: Pending EC decision (X-27-G)

 

Withdrawal of initial marketing authorisation applications

Name of medicine	Feraheme
INN	ferumoxytol
Marketing-authorisation applicant	Covis Pharma Europe B.V.
More information	Feraheme: Pending EC decision

 

Name of medicine	Onteeo
INN	tocilizumab
Marketing-authorisation applicant	Fresenius Kabi Deutschland GmbH
More information	Onteeo is a duplicate of a medicine which is currently under evaluation

 

Name of medicine	Raltegravir Viatris
INN	raltegravir potassium
Marketing-authorisation applicant	Viatris Limited
More information	Raltegravir Viatris: Pending EC decision

 

Other updates

Recommendations on eligibility to PRIME scheme - Adopted at the CHMP meeting of 27-30 March 2023

Reference Number: EMA/898162/2022

Scientific advice and protocol assistance adopted during the CHMP meeting 27-30 March 2023

AdoptedReference Number: EMA/CHMP/SAWP/149934/2023

Overview of invented names reviewed in February 2023 by the Name Review Group adopted at the CHMP meeting of 27-30 March 2023

AdoptedReference Number: EMA/124155/2023