Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024
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10 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its February 2024 meeting.
The committee adopted positive opinions for two vaccines intended for active immunisation against the H5N1 subtype of influenza A virus, also refered to as avian influenza or bird flu. One of them, Celldemic (zoonotic influenza vaccine (H5N1)(surface antigen, inactivated, adjuvanted, prepared in cell cultures)), is intended for immunisation during outbreaks of influenza coming from animals, including when public health authorities anticipate a possible pandemic. The other, Incellipan (pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)), is a pandemic preparedness vaccine intended for use only if a flu pandemic has been officially declared. In the event of a pandemic, once the virus strain causing the pandemic is identified, the manufacturer can include this strain in the authorised pandemic preparedness vaccine and apply for the vaccine to be authorised as a 'final' pandemic vaccine. Because the quality, safety and efficacy of the vaccine has already been assessed with other potential pandemic strains, the authorisation of the final pandemic vaccine can be accelerated.
The CHMP recommended granting a conditional marketing authorisation for Filspari* (sparsentan) for the treatment of primary immunoglobulin A nephropathy, a disease where the kidneys gradually stop working and eventually fail, requiring patients to undergo dialysis or have a kidney transplant.
The CHMP recommended granting a marketing authorisation under exceptional circumstances for Qalsody* (tofersen), a new therapy for the treatment of adult patients with amyotrophic lateral sclerosis (ALS), a rare and often fatal disease that causes muscles to become weak and leads to paralysis. Thismedicine is indicated for the treatment of adults with ALS, who have a mutation in the superoxide dismutase 1 (SOD1) gene. See more details in the news announcement in the grid below.
Tizveni (tislelizumab) received a positive opinion from the CHMP for the treatment of locally advanced or metastatic non-small cell lung cancer in adults.
The CHMP gave a positive opinion for Voydeya* (danicopan), the first oral treatment against residual haemolytic anaemia in patients with paroxysmal nocturnal haemoglobinuria, a rare genetic disorder and potentially life-threatening blood disease leading to the premature destruction of red blood cells by the immune system. This medicine was supported through EMA’s Priority Medicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs. See more details in the news announcement in the grid below.
Zynyz* (retifanlimab) received a positive opinion from the CHMP for the treatment of Merkel cell carcinoma, an aggressive, life-threatening skin cancer with a poor outcome when advanced.
The committee recommended granting a marketing authorisation for Pyzchiva (ustekinumab), a biosimilar medicine intended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease, a disease causing inflammation of the gut.
Two generic medicines also received a positive opinion from the committee: Apremilast Accord (apremilast), for the treatment of psoriatic arthritis, psoriasis and Behçet’s disease, a rare type of inflammatory disease which affects many parts of the body; and Nintedanib Accord (nintedanib) for the treatment of adults with idiopathic pulmonary fibrosis, other chronic fibrosing interstitial lung diseases with a progressive phenotype, and systemic sclerosis associated interstitial lung disease.
Recommendations on extensions of therapeutic indication for six medicines
The committee recommended extensions of indication for six medicines that are already authorised in the European Union (EU): Carvykti*, Cibinqo, Kalydeco, Keytruda, Reblozyl* and Xromi.
Re-examination of recommendations
The applicants for Nezglyal* and Syfovre have requested a re-examination of EMA’s opinions of January 2024. Upon receipt of the grounds of the request, the Agency will re-examine its opinions and issue final recommendations.
Outcome of arbitration procedures
The CHMP completed a review of Ibuprofen NVT following a disagreement among EU Member States regarding its authorisation. The committee considered that bioequivalence of Ibuprofen NVT 400 mg to its reference medicine had not been shown and concluded that the benefits of this medicine do not outweigh its risks. The marketing authorisation granted in Lithuania cannot be recognised in Spain, where the company had applied for a marketing authorisation. In addition, the marketing authorisations in Lithuania and other Member States where the medicine is authorised (Estonia, France, Latvia, Poland and Romania) should be suspended.
For more information, see the Q&A document in the grid below.
Agenda and minutes
The agenda of the February 2024 CHMP meeting is published on EMA's website. Minutes of the meeting will be published in the coming weeks.
CHMP statistics
Key figures from the February 2024 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
Celldemic
- Common name
zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)
- Marketing-authorisation applicant
Seqirus Netherlands B.V.
- Therapeutic indication
Active immunisation for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine.
- More information
Filspari
- International non-proprietary name (INN)
sparsentan
- Marketing-authorisation applicant
Vifor France
- Therapeutic indication
Treatment of primary immunoglobulin A nephropathy (IgAN).
- More information
Incellipan
- Common name
pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)
- Marketing-authorisation applicant
Seqirus Netherlands B.V.
- Therapeutic indication
Prophylaxis of influenza.
- More information
Qalsody
- INN
tofersen
- Marketing-authorisation applicant
Biogen Netherlands B.V.
- Therapeutic indication
Treatment of adults with amyotrophic lateral sclerosis (ALS), associated with a mutation in the superoxide dismutase 1 (SOD1) gene.
- More information
- News
Tizveni
- INN
tislelizumab
- Marketing-authorisation applicant
Beigene Ireland Limited
- Therapeutic indication
Treatment of locally advanced or metastatic non-small cell lung cancer in adults’
- More information
Voydeya
- INN
danicopan
- Marketing-authorisation applicant
Alexion Europe
- Therapeutic indication
Treatment of extravascular haemolysis (EVH) in patients with paroxysmal nocturnal haemoglobinuria.
- More information
- News
Zynyz
- INN
retifanlimab
- Marketing-authorisation applicant
Incyte Biosciences Distribution B.V.
- Therapeutic indication
Treatment of Merkel cell carcinoma (MCC).
- More information
Positive recommendation on a new biosimilar medicine
Pyzchiva
- INN
ustekinumab
- Marketing-authorisation applicant
Samsung Bioepis NL B.V.
- Therapeutic indication
Treatment of Crohn’s disease, Ulcerative colitis, Plaque psoriasis, Paediatric plaque psoriasis and Psoriatic arthritis (PsA).
- More information
Positive recommendations on new generic medicines
Apremilast Accord
- INN
apremilast
- Marketing-authorisation applicant
Accord Healthcare S.L.U.
- Therapeutic indication
Treatment of psoriatic arthritis, psoriasis, Behçet’s disease.
- More information
Nintedanib Accord
- INN
nintedanib
- Marketing-authorisation applicant
Accord Healthcare S.L.U.
- Therapeutic indication
Treatment of idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) and lung diseases (ILDs) systemic sclerosis associated interstitial lung disease (SSc-ILD).
- More information
Re-examination of recommendations for new medicines
Nezglyal
- INN
leriglitazone
- Marketing-authorisation applicant
Minoryx Therapeutics S.L.
- Therapeutic indication
Treatment of cerebral progression and myelopathy in male patients with adrenoleukodystrophy (ALD)
- More information
Syfovre
- INN
pegcetacoplan
- Marketing-authorisation applicant
Apellis Netherlands B.V.
- Therapeutic indication
Treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD)
- More information
Positive recommendations on extensions of indications
Carvykti
- INN
ciltacabtagene autoleucel
- Marketing-authorisation holder
Janssen-Cilag International NV
- More information
Cibinqo
- INN
abrocitinib
- Marketing-authorisation holder
Pfizer Europe MA EEIG
- More information
Kalydeco
- INN
ivacaftor
- Marketing-authorisation holder
Vertex Pharmaceuticals (Ireland) Limited
- More information
Keytruda
- INN
pembrolizumab
- Marketing-authorisation holder
Merck Sharp & Dohme B.V.
- More information
Reblozyl
- INN
luspatercept
- Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
- More information
Xromi
- INN
hydroxycarbamide
- Marketing-authorisation holder
Nova Laboratories Ireland Limited
- More information
Outcome of arbitration procedures
Ibuprofen NVT
- INN
ibuprofen
- Marketing-authorisation holder
Laboratorios Liconsa, S.A.
- More information