Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2022
16 Sep 2022
BiosimilarVaccineADCmRNA
12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its September 2022 meeting.The CHMP recommended granting a marketing authorisation for Beyfortus (nirsevimab) intended for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season (when there is a risk of RSV infection in the community). Beyfortus 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.The committee adopted a positive opinion for Enjaymo* (sutimlimab) for the treatment of haemolytic anaemia (breakdown of red blood cells) in adult patients with cold agglutinin disease, a rare autoimmune disorder characterised by the premature destruction of red blood cells.Livtencity* (maribavir) received a positive opinion for the treatment of adults and paediatric patients with cytomegalovirus infection and/or disease that is refractory to one or more prior therapies. Cytomegalovirus is a type of herpes virus that commonly causes infection after a stem cell or an organ transplant.The committee adopted a positive opinion for Melatonin Neurim (melatonin) for the treatment of insomnia, a sleeping disorder affecting more than 10% of the European Union (EU) population.The CHMP gave a positive opinion for Mycapssa* (octreotide) for the treatment of acromegaly, a rare hormonal disorder where the body produces too much growth hormone. This causes body tissues and bones to grow more quickly, leading e.g. to the enlargement of the hands, feet, forehead, jaw or nose.The committee recommended granting a conditional marketing authorisation for Pyrukynd* (mitapivat) for the treatment of an inherited condition called pyruvate kinase deficiency, a rare genetic disorder characterised by the premature destruction of red blood cells.Zynlonta * (loncastuximab tesirine) received a positive opinion from the CHMP. This medicine is intended for the treatment of adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma, two types of cancer that begin in the lymphatic system when abnormal white blood cells grow.The committee adopted a positive opinion for the biosimilar medicine Ximluci (ranibizumab) for the treatment of neovascular age-related macular degeneration, a progressive retinal macular disease, causing gradual vision impairment, mainly in the elderly population.The CHMP recommended granting a marketing authorisation for Teriparatide SUN (teriparatide) for the treatment of osteoporosis in adults. Osteoporosis affects around 22% of women over the age of 50 in the EU. The recommendation followed 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 CHMP gave a positive opinion for the generic medicine Sorafenib Accord (sorafenib) for the treatment of hepatocellular carcinoma and renal cell carcinoma, two cancers that start in cells or tissues of the liver and kidney.The committee adopted a positive opinion for the generic medicines Teriflunomide Accord and Teriflunomide Mylan (teriflunomide), indicated for the treatment of multiple sclerosis, a chronic disease affecting the central nervous system.Recommendations on extensions of therapeutic indication for 11 medicinesThe committee recommended 12 extensions of indication for medicines that are already authorised in the EU: Adtralza , Biktarvy, Brukinsa, Evusheld , Exparel liposomal, Revolade, Skyrizi, Vaxneuvance, Veklury (includes two extensions of indication for two paediatric populations, see the COVID-19 update below), Xalkori and Yescarta.Withdrawals of initial applicationsThe application for marketing authorisation for Exkivity was withdrawn by the respective applicant. This medicine was indicated for the treatment of a certain type of lung cancer. A question-and-answer document on the withdrawal is available in the grid below.The application for marketing authorisation for Sevsury was withdrawn by the respective applicant. This medicine was indicated for the treatment of progressive neuroendocrine tumours. A question-and-answer document on the withdrawal is available in the grid below.Re-examination concludedThe CHMP confirmed its recommendation to suspend the marketing authorisations of several generic medicines tested by Synchron Research Services, a contract research organisation (CRO) located in Ahmedabad, India. This concludes the re-examination requested by the marketing authorisation holders for some of the medicines concerned. For more information, see the public health communication in the grid below.COVID-19 updateSince the CHMP meeting in July, several recommendations related to COVID-19 vaccines and therapeutics were made.Authorising use of Nuvaxovid as a booster dose for adults who have had Nuvaxovid, an mRNA vaccine or an adenoviral vector vaccine as their primary vaccination. (The recommendation was made on 1 September 2022)Authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron BA.1 are for use in people aged 12 years and above who have received at least primary vaccination against COVID-19. For more information, see the news announcement. (The recommendation was made on 1 September 2022)COVID-19 recommendations adopted during the present meeting of the CHMP:Authorising the adapted bivalent vaccine Comirnaty Original/Omicron BA.4-5 for use in people aged 12 years and above who have received at least a primary course of vaccination against COVID-19. This vaccine is an adapted version of the mRNA COVID-19 vaccine Comirnaty and targets the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. For more information, see the news announcement .Converting the conditional marketing authorisations of the COVID-19 vaccinesCOVID-19 vaccines Comirnaty and Spikevax into standard marketing authorisations. CHMP considered that the additional studies conducted by the companies as part of their post-authorisation obligations have provided ample information on the vaccines’ protection against COVID-19, as well as their quality and safety. For more information, see the news announcement.Approving a new manufacturing site in Dessau-Rosslau, Germany, for COVID-19 Vaccine Valneva.Authorising booster doses of Comirnaty for children from 5 to 11 years of age .Extending the use of COVID-19 therapeutic Evusheld for the treatment of adults and adolescents with COVID-19 who do not require supplemental oxygen.Extending the use of COVID-19 therapeutic Veklury in two paediatric populations:Paediatric patients (of at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen or other non-invasive ventilation at the start of treatment.Paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.Safety updateAt its extraordinary meeting, on 2 September 2022, the CHMP endorsed the recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) and recommended that medicines containing high-dose nomegestrol (3.75 – 5 mg) or high-dose chlormadinone (5 – 10 mg) should be used at the lowest effective dose and for the shortest duration possible, and only when other interventions are not appropriate. In addition, low- and high-dose nomegestrol- or chlormadinone-containing medicines must not be used by patients who have, or have had, meningioma. For more information, see the news announcement .Agenda and minutesThe agenda of the September 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 September 2022 CHMP meeting are represented in the graphic below.
Preview
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 medicineBeyfortusInternational non-proprietary name (INN)nirsevimabMarketing-authorisation applicantAstraZeneca ABTherapeutic indicationPrevention of respiratory syncytial virus lower respiratory tract disease in newborns and infantsMore informationBeyfortus: Pending EC decisionNews announcement: New medicine to protect babies and infants from respiratory syncytial virus (RSV) infection
Name of medicineEnjaymoINNsutimlimabMarketing-authorisation applicantGenzyme Europe BVTherapeutic indicationTreatment of haemolytic anaemia in adult patients with cold agglutinin diseaseMore informationEnjaymo: Pending EC decision
Name of medicineLivtencityINNmaribavirMarketing-authorisation applicantTakeda Pharmaceuticals International AG Ireland BranchTherapeutic indicationTreatment of cytomegalovirus infection and/or disease that is refractory to one or more prior therapiesMore informationLivtencity: Pending EC decision
Name of medicineMelatonin NeurimINNmelatoninMarketing-authorisation applicantRAD Neurim Pharmaceuticals EEC SARLTherapeutic indicationTreatment of insomniaMore informationMelatonin Neurim: Pending EC decision
Name of medicineMycapssaINNoctreotideMarketing-authorisation applicantAmryt Pharmaceuticals DACTherapeutic indicationTreatment of acromegalyMore informationMycapssa: Pending EC decision
Name of medicinePyrukyndINNmitapivatMarketing-authorisation applicantAgios Netherlands B.V.Therapeutic indicationTreatment of pyruvate kinase deficiencyMore informationPyrukynd: Pending EC decision
Name of medicineZynlontaINNloncastuximab tesirineMarketing-authorisation holderADC Therapeutics (NL) B.V.Therapeutic indicationTreatment of adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphomaMore informationZynlonta: Pending EC decision
Positive recommendation on new biosimilar medicine
Name of medicineXimluciINNranibizumabMarketing-authorisation applicantSTADA Arzneimittel AGTherapeutic indicationTreatment of neovascular age-related macular degenerationMore informationXimluci: Pending EC decision
Positive recommendation on new hybrid medicine
Name of medicineTeriparatide SUNINNteriparatideMarketing-authorisation applicantSun Pharmaceutical Industries Europe B.V.Therapeutic indicationTreatment of osteoporosis in adultsMore informationTeriparatide SUN: Pending EC decision
Positive recommendations on new generic medicines
Name of medicineSorafenib AccordINNsorafenibMarketing-authorisation applicantAccord Healthcare S.L.U.Therapeutic indicationTreatment of hepatocellular carcinoma and renal cell carcinomaMore informationSorafenib Accord: Pending EC decision
Name of medicineTeriflunomide AccordINNteriflunomideMarketing-authorisation applicantAccord Healthcare S.L.U.Therapeutic indicationTreatment of multiple sclerosisMore informationTeriflunomide Accord: Pending EC decision
Name of medicineTeriflunomide MylanINNteriflunomideMarketing-authorisation applicantMylan Pharmaceuticals LimitedTherapeutic indicationTreatment of multiple sclerosisMore informationTo be published shortly
Positive recommendations on extensions of indications
Name of medicineBiktarvyINNbictegravir / emtricitabine / tenofovir alafenamideMarketing-authorisation holderGilead Sciences Ireland UCMore informationBiktarvy: Pending EC decision
Name of medicineBrukinsaINNzanubrutinibMarketing-authorisation holderBeiGene Ireland LtdMore informationBrukinsa: Pending EC decision
Name of medicineEvusheldINNtixagevimab / cilgavimabMarketing-authorisation holderAstraZeneca ABMore informationEvusheld: Pending EC decision
Name of medicineExparel liposomalINNbupivacaineMarketing-authorisation holderPacira Ireland LimitedMore informationExparel liposomal: Pending EC decision
Name of medicineRevoladeINNeltrombopagMarketing-authorisation holderNovartis Europharm LimitedMore informationRevolade: Pending EC decision
Name of medicineSkyriziINNrisankizumabMarketing-authorisation holderAbbVie Deutschland GmbH & Co. KGMore informationSkyrizi: Pending EC decision
Name of medicineVaxneuvanceCommon namepneumococcal polysaccharide conjugate vaccine (adsorbed)Marketing-authorisation holderMerck Sharp & Dohme B.V.More informationVaxneuvance: Pending EC decision
Name of medicineVekluryINNremdesivirMarketing-authorisation holderGilead Sciences Ireland UCMore informationVeklury: Pending EC decision
Name of medicineXalkoriINNcrizotinibMarketing-authorisation holderPfizer Europe MA EEIGMore informationXalkori: Pending EC decision
Name of medicineYescartaINNaxicabtagene ciloleucelMarketing-authorisation holderKite Pharma EU B.V.More informationYescarta: Pending EC decision
Withdrawals of initial marketing authorisation applications
Name of medicineExkivityINNmobocertinibMarketing-authorisation applicantTakeda Pharma A/SMore informationExkivity: Withdrawn application
Name of medicineSevsuryINNsurufatinibMarketing-authorisation applicantHutchmed Europe B.V. More informationSevsury: Withdrawn application
Outcome of referral re-examination
Name of medicineSynchron Research ServicesMore informationSynchron
Other updates
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Scientific advice and protocol assistance adopted during the CHMP meeting 12-15 September 2022
(PDF/230.36 KB)
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Adopted
First published:
16/09/2022
EMA/CHMP/SAWP/769857/2022
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