Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2022
14 Oct 2022
VaccineBiosimilar
10 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 10 medicines for approval at its October 2022 meeting.The CHMP recommended granting a marketing authorisation for Dengue Tetravalent Vaccine (Live, Attenuated) Takeda for the prevention of dengue virus serotypes 1, 2, 3 and 4 in people from four years of age. Dengue is a mosquito-borne tropical disease caused by the dengue virus, leading to mild flu-like symptoms in most people. However, a small number of patients develop severe disease, with potentially fatal bleeding and organ damage. The global estimated death rate is 20,000 to 25,000 per year, primarily in children. Dengue tetravalent vaccine prevents fever, severe disease and hospitalisation caused by any of the four serotypes of the dengue virus. This vaccine received an EMA recommendation under the EU Medicines for all (EU-M4All) programme, a mechanism that allows the CHMP to assess medicines that are intended for use in low- and middle-income countries outside of the European Union (EU). Simultaneously, the vaccine has also received a positive opinion for use in the EU, under the trade name Qdenga. See more information in the news announcement in the grid below.The committee adopted a positive opinion for a marketing authorisation under exceptional circumstances for the advanced therapy medicinal product (ATMP) Ebvallo* (tabelecleucel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease. This ATMP is intended for adult and paediatric patients who experience a serious complication following solid organ transplantation or bone marrow transplantation. Ebvallo was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. See more information in the news announcement in the grid below.Eladynos (abaloparatide) received a positive opinion for the treatment of osteoporosis in postmenopausal women at increased risk of fractures.The committee recommended granting a marketing authorisation under exceptional circumstances for Livmarli* (maralixibat chloride) intended for the treatment of cholestatic pruritus (itching) in adult and paediatric patients from two months of age with Alagille syndrome, an inherited condition in which bile builds up in the liver.The CHMP gave a positive opinion for Locametz (gozetotide), which is intended for the diagnosis of prostate cancer.The committee adopted a positive opinion for Pluvicto (lutetium (177Lu) vipivotide tetraxetan) for the treatment of prostate cancer.Spevigo (spesolimab) received a positive opinion for a conditional marketing authorisation for the treatment of flares in adult patients with generalised pustular psoriasis, a skin disorder that consists of pus spots surrounded by areas of red skin.The committee adopted positive opinions for three generic medicines:Dimethyl fumarate Teva (dimethyl fumarate), indicated for the treatment of adult and paediatric patients aged 13 years and older with multiple sclerosis, a chronic disease affecting the central nervous system.Pemetrexed Baxter (pemetrexed) for the treatment of malignant pleural mesothelioma, a rare cancer of the lining around the lungs, and non-small cell lung cancer.Plerixafor Accord (plerixafor) for the treatment of adults and children with lymphoma and multiple myeloma, two types of white blood cells cancers.Recommendations on extensions of therapeutic indication for four medicinesThe committee recommended four extensions of indication for medicines that are already authorised in the EU: Brukinsa, Libtayo, Lyumjev and Xydalba.Withdrawals of initial applicationsThe applications for marketing authorisation for biosimilar medicines Tuznue and Hervelous were withdrawn by the applicant during the re-examination of the negative opinions that the committee adopted at its May 2022 meeting. These medicines were intended for the treatment of certain forms of breast cancer and gastric (stomach) cancer. A question-and-answer document on the withdrawals is available in the grid below.COVID-19 updateThe committee recommended converting the conditional marketing authorisation of the COVID-19 vaccine Vaxzevria to a standard marketing authorisation.Agenda and minutesThe agenda of the October 2022 CHMP meeting is published on EMA's website. Minutes of the September 2022 CHMP meeting will be published in the coming weeks.CHMP statisticsKey figures from the October 2022 CHMP meeting are represented in the graphic below.
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Source: ema
*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
Name of medicineEbvalloInternational non-proprietary name (INN)tabelecleucelMarketing-authorisation applicantAtara Biotherapeutics Ireland LimitedTherapeutic indicationTreatment of Epstein-Barr virus positive post-transplant lymphoproliferative diseaseMore informationEbvallo: Pending EC decisionNews announcement: First therapy to treat transplant patients with post-transplant lymphoproliferative disease
Name of medicineEladynosINNabaloparatideMarketing-authorisation applicantRadius Health Ireland LtdTherapeutic indicationTreatment of osteoporosis in postmenopausal women at increased risk of fractureMore informationEladynos: Pending EC decision
Name of medicineLivmarliINNmaralixibat chlorideMarketing-authorisation applicantMirum Pharmaceuticals International B.V.Therapeutic indicationTreatment of cholestatic pruritus in patients with Alagille syndromeMore informationLivmarli: Pending EC decision
Name of medicineLocametzINNgozetotideMarketing-authorisation applicantNovartis Europharm LimitedTherapeutic indicationDiagnosis of prostate cancerMore informationLocametz: Pending EC decision
Name of medicineQdengaCommon namedengue tetravalent vaccine (live, attenuated)Marketing-authorisation applicantTakeda GmbHTherapeutic indicationPrevention of dengue diseaseMore informationQdenga: Pending EC decision
Name of medicinePluvictoINNlutetium (177Lu) vipivotide tetraxetanMarketing-authorisation applicantNovartis Europharm LimitedTherapeutic indicationTreatment of prostate cancerMore informationPluvicto: Pending EC decision
Name of medicineSpevigoINNspesolimabMarketing-authorisation applicantBoehringer Ingelheim International GmbHTherapeutic indicationTreatment of flares in adult patients with generalised pustular psoriasisMore informationSpevigo: Pending EC decision
Positive recommendations on new generic medicines
Name of medicineDimethyl fumarate TevaINNdimethyl fumarateMarketing-authorisation holderTEVA GmbHTherapeutic indicationTreatment of multiple sclerosisMore informationDimethylfumarate Teva: Pending EC decision
Name of medicinePemetrexed BaxterINNpemetrexedMarketing-authorisation applicantBaxter Holding B.V.Therapeutic indicationTreatment of malignant pleural mesothelioma and non-small cell lung cancerMore informationPemetrexed Baxter: Pending EC decision
Name of medicinePlerixafor AccordINNplerixaforMarketing-authorisation applicantAccord Healthcare S.L.U.Therapeutic indicationTreatment of lymphoma and multiple myelomaMore informationTo be published shortly
Positive recommendations on extensions of indications
Name of medicineBrukinsaINNzanubrutinibMarketing-authorisation holderBeiGene Ireland LtdMore informationBrukinsa: Pending EC decision
Name of medicineLibtayoINNcemiplimabMarketing-authorisation holderRegeneron Ireland Designated Activity Company (DAC)More informationLibtayo: Pending EC decision
Name of medicineLyumjevINNinsulin lisproMarketing-authorisation holderEli Lilly Nederland B.V.More informationLyumjev: Pending EC decision
Name of medicineXydalbaINNdalbavancinMarketing-authorisation holderAbbVie Deutschland GmbH & Co. KGMore informationXydalba: Pending EC decision
Withdrawals of initial marketing authorisation applications
Name of medicineHervelousINNtrastuzumab Marketing-authorisation applicantPrestige Biopharma Belgium More informationHervelous: Withdrawn application
Name of medicineTuznueINNtrastuzumab Marketing-authorisation applicantPrestige Biopharma BelgiumMore informationTuznue: Withdrawn application
Positive recommendations on medicines for use outside the European Union
Name of medicineDengue Tetravalent Vaccine (Live, Attenuated) TakedaCommon namedengue tetravalent vaccine (live, attenuated)More informationDengue Tetravalent Vaccine (Live, Attenuated) TakedaNews announcement: New vaccine to protect people in the EU and worldwide against dengue
Other updates
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Overview of (invented) names reviewed in September 2022 by the Name Review Group (NRG) adopted at the CHMP meeting of 10-13 October 2022
(PDF/142.16 KB)
(new)
Adopted
First published:
14/10/2022
EMA/825713/2022
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Scientific advice and protocol assistance adopted during the CHMP meeting 10-13 October 2022
(PDF/242.62 KB)
(new)
Adopted
First published:
14/10/2022
EMA/CHMP/SAWP/827118/2022
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