EMA: eeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2024

Europe

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. This medicine 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.

 

(ema.europa.eu)

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