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.
| Name of medicine | Enhertu |
| INN | trastuzumab deruxtecan |
| Marketing-authorisation applicant | Daiichi Sankyo Europe GmbH |
| Therapeutic indication | Treatment of metastatic HER2-positive breast cancer |
| More information | Enhertu: Pending EC decision |
| Name of medicine | Heplisav B |
| INN | hepatitis B surface antigen |
| Marketing-authorisation applicant | Dynavax GmbH |
| Therapeutic indication | Active immunisation against hepatitis B virus infection |
| More information | Heplisav B: Pending EC decision |
| Name of medicine | Inrebic |
| INN | fedratinib |
| Marketing-authorisation applicant | Celgene Europe BV |
| Therapeutic indication | Treatment of primary myelofibrosis and of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia |
| More information | Inrebic: Pending EC decision |
| Name of medicine | Lumoxiti |
| INN | moxetumomab pasudotox |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Treatment of relapsed or refractory hairy cell leukaemia |
| More information | Lumoxiti: Pending EC decision |
| Name of medicine | Retsevmo |
| INN | selpercatinib |
| Marketing-authorisation applicant | Eli Lilly Nederland B.V. |
| Therapeutic indication | Treatment 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 information | Retsevmo: Pending EC decision |
| Name of medicine | Rukobia |
| INN | fostemsavir |
| Marketing-authorisation applicant | ViiV Healthcare B.V. |
| Therapeutic indication | Treatment of multidrug resistant HIV-1 infection |
| More information | Rukobia: Pending EC decision |
| Name of medicine | Sibnayal |
| INN | potassium citrate / potassium hydrogen carbonate |
| Marketing-authorisation applicant | Advicenne S.A. |
| Therapeutic indication | Treatment of distal renal tubular acidosis |
| More information | Sibnayal: Pending EC decision |
| Name of medicine | Tukysa |
| INN | tucatinib |
| Marketing-authorisation applicant | Seagen B.V. |
| Therapeutic indication | Treatment of HER2-positive locally advanced or metastatic breast cancer |
| More information | Tukysa: Pending EC decision |
| Name of medicine | Kixelle |
| INN | insulin aspart |
| Marketing-authorisation applicant | Mylan IRE Healthcare Limited |
| Therapeutic indication | Treatment of diabetes mellitus |
| More information | Kixelle: Pending EC decision |
| Name of medicine | Yuflyma |
| INN | adalimumab |
| Marketing-authorisation applicant | Celltrion Healthcare Hungary Kft. |
| Therapeutic indication | Treatment of certain inflammatory and autoimmune disorders |
| More information | Yuflyma: Pending EC decision |
| Name of medicine | Lenalidomide Krka |
| INN | lenalidomide |
| Marketing-authorisation applicant | KRKA, d.d., Novo mesto |
| Therapeutic indication | Treatment of multiple myeloma and follicular lymphoma |
| More information | Lenalidomide Krka: Pending EC decision |
| Name of medicine | Lenalidomide Krka d.d. |
| INN | lenalidomide |
| Marketing-authorisation applicant | KRKA, d.d., Novo mesto |
| Therapeutic indication | Treatment of multiple myeloma, myelodysplastic syndromes and follicular lymphoma |
| More information | Lenalidomide Krka d.d.: Pending EC decision |
| Name of medicine | Lenalidomide Krka d.d. Novo mesto |
| INN | lenalidomide |
| Marketing-authorisation applicant | KRKA, d.d., Novo mesto |
| Therapeutic indication | Treatment of multiple myeloma, myelodysplastic syndromes, mantle cell lymphoma and follicular lymphoma |
| More information | Lenalidomide Krka d.d. Novo mesto: Pending EC decision |
| Name of medicine | Sunitinib Accord |
| INN | sunitinib |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of cancer |
| More information | Sunitinib Accord: Pending EC decision |
| Name of medicine | Ogluo |
| INN | glucagon |
| Marketing-authorisation applicant | XerisPharmaceuticals Ireland Limited |
| Therapeutic indication | Treatment of severe hypoglycaemia in diabetes mellitus |
| More information | Ogluo: Pending EC decision |
| Name of medicine | Bavencio |
| INN | avelumab |
| Marketing-authorisation holder | Merck Europe B.V. |
| More information | Bavencio: Pending EC decision |
| Name of medicine | Doptelet |
| INN | avatrombopag |
| Marketing-authorisation holder | Swedish Orphan Biovitrum AB (publ) |
| More information | Doptelet: Pending EC decision |
| Name of medicine | Iscover |
| INN | clopidogrel |
| Marketing-authorisation holder | sanofi-aventis groupe |
| More information | Iscover: Pending EC decision |
| Name of medicine | Keytruda |
| INN | pembrolizumab |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information | Keytruda: Pending EC decision |
| Name of medicine | Nplate |
| INN | romiplostim |
| Marketing-authorisation holder | Amgen Europe B.V |
| More information | Nplate: Pending EC decision |
| Name of medicine | Nordimet |
| INN | methotrexate |
| Marketing-authorisation holder | Nordic Group B.V. |
| More information | Nordimet: Pending EC decision |
| Name of medicine | Plavix |
| INN | clopidogrel |
| Marketing-authorisation holder | sanofi-aventis groupe |
| More information | Plavix: Pending EC decision |
| Name of medicine | Rinvoq |
| INN | upadacitinib |
| Marketing-authorisation holder | AbbVie Deutschland GmbH & Co. KG |
| More information | Rinvoq: Pending EC decision |
| Name of medicine | Spravato |
| INN | esketamine |
| Marketing-authorisation holder | Janssen-Cilag International N.V. |
| More information | Spravato: Pending EC decision |
| Name of medicine | Artobend |
| INN | autologous human chondrocytes in vitro expanded |
| Marketing-authorisation applicant | TETEC Tissue Engineering Technologies AG |
| More information | Artobend: Withdrawn application |
| Name of medicine | Veklury |
| INN | remdesivir |
| Marketing-authorisation holder | Gilead Sciences Ireland UC |
| More information | Veklury: Pending EC decision |