Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020

News 11/12/2020

Fifteen new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended 15 medicines for approval at its December 2020 meeting.

The Committee recommended granting a conditional marketing authorisation for Enhertu (trastuzumab deruxtecan) for the treatment of metastatic HER2-positive breast cancer. Enhertu was reviewed under EMA’s accelerated assessment programme.

The CHMP adopted a positive opinion for Heplisav B (hepatitis B surface antigen) for the active immunisation against hepatitis B virus infection.

Inrebic* (fedratinib) received a positive opinion for the treatment of primary myelofibrosis (an uncommon type of bone marrow cancer) and of myelofibrosis secondary to polycythaemia vera (a type of blood cancer) or essential thrombocythaemia (a rare chronic blood cancer).

The Committee recommended granting a marketing authorisation under exceptional circumstances for Lumoxiti* (moxetumomab pasudotox) for the treatment of relapsed or refractory hairy cell leukaemia, a cancer of a type of white blood cell called B-lymphocytes.

The Committee recommended granting a conditional marketing authorisation for Retsevmo (selpercatinib) for the treatment of cancers that display a rearranged during transfection (RET) gene fusion: RET-fusion positive non-small cell lung cancer, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer.

Rukobia (fostemsavir) received a positive opinion for the treatment of multidrug resistant HIV-1 infection.

The CHMP recommended granting a marketing authorisation for Sibnayal* (potassium citrate / potassium hydrogen carbonate) for the treatment of distal renal tubular acidosis, a rare genetic disorder that affects the ability of the kidneys to remove acid from the blood.

Tukysa (tucatinib) received a positive opinion for the treatment of HER2-positive locally advanced or metastatic breast cancer.

The CHMP recommended granting marketing authorisations for two biosimilar medicines: Kixelle (insulin aspart), for the treatment of diabetes mellitus; and Yuflyma (adalimumab), for the treatment of certain inflammatory and autoimmune disorders.

The CHMP recommended granting marketing authorisations for four generic medicines: Lenalidomide Krka (lenalidomide), for the treatment of multiple myeloma and follicular lymphoma; Lenalidomide Krka d.d. (lenalidomide), for the treatment of multiple myeloma, myelodysplastic syndromes, and follicular lymphoma; Lenalidomide Krka d.d. Novo mesto (lenalidomide), for the treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma; and Sunitinib Accord (sunitinib), for the treatment of cancer.

The CHMP recommended granting a marketing authorisation for Ogluo (glucagon), a hybrid medicine for the treatment of severe hypoglycaemia in diabetes mellitus. 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.

Nine recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Bavencio, Doptelet, Iscover, Keytruda, Nplate, Nordimet, Plavix, Rinvoq and Spravato.

Restriction of indication for Veklury

The CHMP adopted a positive opinion recommending a change to the product information for Veklury (remdesivir) to provide clearer instructions in which COVID-19 patients requiring supplementary oxygen it should be used. More information on the new indication is available on the summary of opinion document in the grid below.

Withdrawal of application

The application for an initial marketing authorisation for Artobend (autologous human chondrocytes in vitro expanded) was withdrawn. This advanced therapy medicinal product (ATMP) was intended for the treatment of cartilage defects of the knee joint.

A question-and-answer document on this withdrawal is available in the grid below.

Agenda and minutes

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

CHMP statistics

Key figures from the December 2020 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.

CHMP statistics: December 2020

Positive recommendations on new medicines

Name of medicineEnhertu
INNtrastuzumab deruxtecan
Marketing-authorisation applicantDaiichi Sankyo Europe GmbH
Therapeutic indicationTreatment of metastatic HER2-positive breast cancer
More informationEnhertu: Pending EC decision

 

Name of medicineHeplisav B
INNhepatitis B surface antigen
Marketing-authorisation applicantDynavax GmbH
Therapeutic indicationActive immunisation against hepatitis B virus infection
More informationHeplisav B: Pending EC decision

 

Name of medicineInrebic
INNfedratinib
Marketing-authorisation applicantCelgene Europe BV
Therapeutic indicationTreatment of primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia
More informationInrebic: Pending EC decision

 

Name of medicineLumoxiti
INNmoxetumomab pasudotox
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of relapsed or refractory hairy cell leukaemia
More informationLumoxiti: Pending EC decision

 

Name of medicineRetsevmo
INNselpercatinib
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of cancers that display rearranged during transfection (RET) gene alterations: RET-fusion positive non-small cell lung cancer, RET-fusion positive thyroid cancer and RET-mutant medullary-thyroid cancer
More informationRetsevmo: Pending EC decision

 

Name of medicineRukobia
INNfostemsavir
Marketing-authorisation applicantViiV Healthcare B.V.
Therapeutic indicationTreatment of multidrug resistant HIV-1 infection
More informationRukobia: Pending EC decision

 

Name of medicineSibnayal
INNpotassium citrate / potassium hydrogen carbonate
Marketing-authorisation applicantAdvicenne S.A.
Therapeutic indicationTreatment of distal renal tubular acidosis
More informationSibnayal: Pending EC decision

 

Name of medicineTukysa
INNtucatinib
Marketing-authorisation applicantSeagen B.V.
Therapeutic indicationTreatment of HER2-positive locally advanced or metastatic breast cancer
More informationTukysa: Pending EC decision

 

Positive recommendations on new biosimilar medicines

Name of medicineKixelle
INNinsulin aspart
Marketing-authorisation applicantMylan IRE Healthcare Limited
Therapeutic indicationTreatment of diabetes mellitus
More informationKixelle: Pending EC decision

 

Name of medicineYuflyma
INNadalimumab
Marketing-authorisation applicantCelltrion Healthcare Hungary Kft.
Therapeutic indicationTreatment of certain inflammatory and autoimmune disorders
More informationYuflyma: Pending EC decision

 

Positive recommendations on new generic medicines

Name of medicineLenalidomide Krka
INNlenalidomide
Marketing-authorisation applicantKRKA, d.d., Novo mesto
Therapeutic indicationTreatment of multiple myeloma and follicular lymphoma
More informationLenalidomide Krka: Pending EC decision

 

Name of medicineLenalidomide Krka d.d.
INNlenalidomide
Marketing-authorisation applicantKRKA, d.d., Novo mesto
Therapeutic indicationTreatment of multiple myeloma, myelodysplastic syndromes and follicular lymphoma
More informationLenalidomide Krka d.d.: Pending EC decision

 

Name of medicineLenalidomide Krka d.d. Novo mesto
INNlenalidomide
Marketing-authorisation applicantKRKA, d.d., Novo mesto
Therapeutic indicationTreatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma
More informationLenalidomide Krka d.d. Novo mesto: Pending EC decision

 

Name of medicineSunitinib Accord
INNsunitinib
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of cancer
More informationSunitinib Accord: Pending EC decision

 

Positive recommendation on a new hybrid medicine

Name of medicineOgluo
INNglucagon
Marketing-authorisation applicantXerisPharmaceuticals Ireland Limited
Therapeutic indicationTreatment of severe hypoglycaemia in diabetes mellitus
More informationOgluo: Pending EC decision

 

Positive recommendations on extensions of indications

Name of medicineBavencio
INNavelumab
Marketing-authorisation holderMerck Europe B.V.
More informationBavencio: Pending EC decision

 

Name of medicineDoptelet
INNavatrombopag
Marketing-authorisation holderSwedish Orphan Biovitrum AB (publ)
More informationDoptelet: Pending EC decision

 

Name of medicineIscover
INNclopidogrel
Marketing-authorisation holdersanofi-aventis groupe
More informationIscover: Pending EC decision

 

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holderMerck Sharp & Dohme B.V.
More informationKeytruda: Pending EC decision

 

Name of medicineNplate
INNromiplostim
Marketing-authorisation holderAmgen Europe B.V
More informationNplate: Pending EC decision

 

Name of medicineNordimet
INNmethotrexate
Marketing-authorisation holderNordic Group B.V.
More informationNordimet: Pending EC decision

 

Name of medicinePlavix
INNclopidogrel
Marketing-authorisation holdersanofi-aventis groupe
More informationPlavix: Pending EC decision

 

Name of medicineRinvoq
INNupadacitinib
Marketing-authorisation holderAbbVie Deutschland GmbH & Co. KG
More informationRinvoq: Pending EC decision

 

Name of medicineSpravato
INNesketamine
Marketing-authorisation holderJanssen-Cilag International N.V.
More informationSpravato: Pending EC decision

 

Withdrawal of initial marketing authorisation application

Name of medicineArtobend
INNautologous human chondrocytes in vitro expanded
Marketing-authorisation applicantTETEC Tissue Engineering Technologies AG
More informationArtobend: Withdrawn application

 

Other opinions

Name of medicineVeklury
INNremdesivir
Marketing-authorisation holderGilead Sciences Ireland UC
More informationVeklury: Pending EC decision

 

How useful was this page?

Add your rating
Average
3 ratings