Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2020

News 26/06/2020

Eight new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its June 2020 meeting.

The Committee recommended granting a conditional marketing authorisation for Veklury (remdesivir), for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU. For more information, see the press release published on 25 June 2020 in the grid below.

The CHMP recommended granting a conditional marketing authorisation for Idefirix* (imlifidase), the first treatment for adult patients waiting for a kidney transplant who are highly sensitised against tissue from the donor and who have a positive crossmatch test against an available kidney from a deceased donor. Idefirix benefited from the support of the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. For more information, see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Kaftrio* (elexacaftor / tezacaftor / ivacaftor), the first triple combination therapy for the treatment of cystic fibrosis in patients aged 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or heterozygous for F508del in the CFTR gene with a minimal function (MF) mutation. This treatment is expected to provide a new therapeutic option for many cystic fibrosis patients, including those with MF mutations where no treatment exists. For more information, see the press release in the grid below.

The CHMP recommended granting marketing authorisations for three biosimilar medicines: Aybintio (bevacizumab), for the treatment of various cancers; and Livogiva (teriparatide) and its duplicate Qutavina (teriparatide), for the treatment of osteoporosis.

The Committee recommended granting marketing authorisations for two hybrid medicines: Gencebok (caffeine citrate), for the treatment of primary apnoea (interruption of breathing) of premature newborns; and Methylthioninium chloride Cosmo (methylthioninium chloride), intended as a diagnostic agent to enhance visualisation of colorectal lesions. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.

Negative opinion on a new medicine

The CHMP adopted a negative opinion recommending the refusal of a marketing authorisation for Turalio (pexidartinib). Turalio was expected to be used to treat tenosynovial giant cell tumours. For more information see the question-and-answer document in the grid below.

Five recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Cosentyx, Epclusa, Remsima, Xolair and Zavicefta.

Start of referral

The Committee started a review of the vaccine Varilrix, (live attenuated varicella virus (OKA strain)) to harmonise the way it is used in the countries where it is available the EU. Varilrix is used for protecting individuals against varicella (chickenpox). For more information, see the start-of-referral document in the grid below.

Start of re-examination of recommendation on ranitidine medicines

Following the CHMP’s recommendation of April 2020 to suspend all ranitidine medicines in the EU, one of the marketing authorisation holders involved with this review has requested a re-examination. Upon receipt of the grounds for the request, the CHMP will start a re-examination and issue its final recommendation.

For more information on this review, see the public health recommendation in the grid below.

Withdrawals of applications

Applications for initial marketing authorisations for Sondelbay (teriparatide), Xiidra (lifitegrast) and Zemdri (plazomicin) have been withdrawn.

Sondelbay was expected to be used to treat osteoporosis. Xiidra was intended for the treatment of dry eye disease. Zemdri was intended for the treatment of complicated urinary tract infection.

Question-and-answer documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the June meeting is published on EMA's website. Minutes of the May 2020 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the June 2020 CHMP meeting are represented in the graphic below.


* These products were designated as an orphan medicines during their 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 medicines' orphan status and granting the medicines ten years of market exclusivity.

CHMP statistics: June 2020

Positive recommendations on new medicines

Name of medicine Idefirix
INN imlifidase
Marketing-authorisation applicant Hansa Biopharma AB
Therapeutic indication Desensitisation of highly sensitised patients needing kidney transplantation, but unlikely to receive a compatible transplant
More information

Idefirix: Pending EC decision

Press release: New treatment to enable kidney transplant in highly sensitised patients

Name of medicine Kaftrio
INN elexacaftor / tezacaftor / ivacaftor
Marketing-authorisation applicant Vertex Pharmaceuticals (Ireland) Limited
Therapeutic indication Treatment of cystic fibrosis in patients aged 12 years and older who are homozygous for the F508del mutation or heterozygous for the F508del in the CFTR gene with a minimal function mutation (MF) (corresponding to either no production of a CFTR protein or a CFTR protein that is not responsive to ivacaftor and tezacaftor/ivacaftor in vitro)
More information

Kaftrio: Pending EC decision

Press release: New medicine for cystic fibrosis patients

Name of medicine Veklury
INN remdesivir
Marketing-authorisation applicant Gilead Sciences Ireland UC
Therapeutic indication Treatment of (SARS-CoV-2), a novel coronavirus causing a respiratory illness designated as coronavirus disease 2019, or COVID-19
More information

Press release: First COVID-19 treatment recommended for EU authorisation

Positive recommendations on new biosimilar medicines

Name of medicine Aybintio
INN bevacizumab
Marketing-authorisation applicant Samsung Bioepis NL B.V.
Therapeutic indication Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
More information Aybintio: Pending EC decision

Name of medicine Livogiva
INN teriparatide
Marketing-authorisation applicant Theramex Ireland Limited
Therapeutic indication Treatment of osteoporosis
More information Livogiva: Pending EC decision

Name of medicine Qutavina
INN teriparatide
Marketing-authorisation applicant EuroGenerics Holdings B.V.
Therapeutic indication Treatment of osteoporosis
More information Qutavina: Pending EC decision

Positive recommendations on new hybrid medicines

Name of medicine Gencebok
INN caffeine citrate
Marketing-authorisation applicant Gennisium Pharma
Therapeutic indication Treatment of primary apnoea of premature newborns
More information Gencebok: Pending EC decision

Name of medicine Methylthioninium chloride Cosmo
Common name methylthioninium chloride
Marketing-authorisation applicant Cosmo Technologies Ltd
Therapeutic indication Diagnostic agent to enhance visualisation of colorectal lesions
More information Methylthioninium chloride Cosmo: Pending EC decision

Negative recommendation on new medicine

Name of medicine Turalio
INN pexidartinib
Marketing-authorisation applicant Daiichi Sankyo Europe GmbH
Therapeutic indication Treatment of tenosynovial giant cell tumour
More information Turalio: Pending EC decision

Positive recommendations on extensions of indications

Name of medicine Cosentyx
INN secukinumab
Marketing-authorisation holder Novartis Europharm Limited
More information Cosentyx: Pending EC decision

Name of medicine Epclusa
INN sofosbuvir / velpatasvir
Marketing-authorisation holder Gilead Sciences Ireland UC
More information Epclusa: Pending EC decision

Name of medicine Remsima
INN infliximab
Marketing-authorisation holder Celltrion Healthcare Hungary Kft.
More information

Name of medicine Xolair
INN omalizumab
Marketing-authorisation holder Novartis Europharm Limited
More information Xolair: Pending EC decision

Name of medicine Zavicefta
INN ceftazidime / avibactam
Marketing-authorisation holder Pfizer Ireland Pharmaceuticals
More information Zavicefta: Pending EC decision

Outcome of re-examination of arbitration procedure

Name of medicine Budesonide SUN
INN budesonide
Marketing-authorisation holder Sun Pharmaceutical Industries Europe B.V.
More information Article-29(4) referral: Budesonide SUN

Start of harmonisation procedure

Name of medicine Varilrix
Marketing-authorisation holder GlaxoSmithKline Biologicals
More information Article-30 referral: Varilrix

Start of re-examination of public-health recommendation

Name of medicine Ranitidine-containing medicinal products
More information Article-31 referral: Ranitidine-containing medicinal products

Withdrawals of initial marketing authorisation applications

Name of medicine Sondelbay
INN teriparatide
Marketing-authorisation applicant Accord Healthcare S.L.U.
More information Sondelbay: Withdrawn application

Name of medicine Xiidra
INN lifitegrast
Marketing-authorisation applicant Novartis Europharm Limited
More information Xiidra: Withdrawn application

Name of medicine Zemdri
INN plazomicin
Marketing-authorisation applicant Cipla Europe NV
More information Zemdri: Withdrawn application

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