EMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its January 2021 meeting.
The Committee recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca (COVID-19 Vaccine (ChAdOx1-S [recombinant])) to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the third COVID-19 vaccine that EMA has recommended for authorisation. For more information, see the press release in the grid below.
Seffalair Spiromax (salmeterol / fluticasone) and its duplicate BroPair Spiromax (salmeterol / fluticasone) received a positive opinion for the treatment of asthma in adults and adolescents aged 12 years and older.
The Committee recommended granting a marketing authorisation for Byfavo (remimazolam) for procedural sedation.
Kesimpta (ofatumumab) received a positive opinion from the Committee for the treatment of adult patients with active relapsing forms of multiple sclerosis.
The CHMP recommended granting a conditional marketing authorisation for Nexpovio* (selinexor) for the treatment of relapsed and refractory multiple myeloma.
Ontozry (cenobamate) received a positive opinion for the treatment of adults with epilepsy whose disease is not adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products.
The Committee recommended granting a conditional marketing authorisation for Pemazyre* (pemigatinib) for the second-line treatment of advanced or metastatic cholangiocarcinoma (bile duct cancer) characterized by fusion or rearrangements of fibroblast growth factor receptor 2.
Sogroya* (somapacitan) received a positive opinion from the CHMP for the treatment of growth hormone deficiency in adults.
The Committee recommended granting a marketing authorisation for Vazkepa (icosapent ethyl) to reduce the risk of cardiovascular events in patients at high cardiovascular risk.
Two biosimilar medicines, Alymsys (bevacizumab) and Oyavas (bevacizumab), received a positive opinion for the 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.
The generic medicine Thiotepa Riemser (thiotepa) received a positive opinion for use as a conditioning treatment before haematopoietic progenitor cell (cells that make blood cells) transplantation.
The Committee recommended extensions of indication for Keytruda, Sirturo and Vaxchora.
The CHMP also recommended the addition of a new strength (150 mg), a new pharmaceutical form (solution for injection) and a new route of administration (subcutaneous use) for Tysabri, a multiple sclerosis medicine already authorised for intravenous use.
The CHMP has updated the product information for the COVID-19 vaccine Comirnaty to clarify its position on the interval between the first and second dose. The product information (section 4.2 and package leaflet) now recommends the administration of the second dose 3 weeks after the first dose. Previously, the product information stated that the interval should be “at least 21 days”.
For more information, see the communication published on 28 January 2021 on EMA’s website.
The application for an initial marketing authorisation for Dexamethasone Taw (dexamethasone phosphate) was withdrawn. This medicine was intended for the treatment of several inflammatory and other conditions.
The application to extend the use of Tecentriq (atezolizumab) to treat advanced or metastatic urothelial cancer in combination with platinum-based therapy in patients who had not been treated before was also withdrawn.
Question-and-answer documents on these withdrawals are available in the grid below.
The agenda of the January meeting is published on EMA's website. Minutes of the December 2020 CHMP meeting will be published in the coming weeks.
Exceptionally, due to the extended meeting timetable, most of the associated documents will only become available from Monday 1 February 2021.
CHMP statistics
Key figures from the January 2021 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 | BroPair Spiromax |
| INN | salmeterol / fluticasone |
| Marketing-authorisation applicant | Teva B.V. |
| Therapeutic indication | Treatment of asthma in adults and adolescents aged 12 years and older |
| More information | BroPair Spiromax: Pending EC decision |
| Name of medicine | Byfavo |
| INN | remimazolam |
| Marketing-authorisation applicant | PAION Netherlands B.V. |
| Therapeutic indication | Procedural sedation |
| More information | Byfavo: Pending EC decision |
| Name of medicine | COVID-19 Vaccine AstraZeneca |
| Common name | COVID-19 Vaccine (ChAdOx1-S [recombinant]) |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Prevention of coronavirus disease 2019 (COVID-19) in people aged 18 years and older |
| More information |
Vaxzevria (previously COVID-19 Vaccine AstraZeneca): Pending EC decision News:EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU |
| Name of medicine | Kesimpta |
| INN | ofatumumab |
| Marketing-authorisation applicant | Novartis Ireland Ltd |
| Therapeutic indication | Treatment of adult patients with active relapsing forms of multiple sclerosis |
| More information | Kesimpta: Pending EC decision |
| Name of medicine | Nexpovio |
| INN | selinexor |
| Marketing-authorisation applicant | Karyopharm Europe GmbH |
| Therapeutic indication | Treatment of relapsed and refractory multiple myeloma |
| More information | Nexpovio: Pending EC decision |
| Name of medicine | Ontozry |
| INN | cenobamate |
| Marketing-authorisation applicant | Arvelle Therapeutics Netherlands B.V. |
| Therapeutic indication | Treatment of adults with epilepsy whose disease is not adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products |
| More information | Ontozry: Pending EC decision |
| Name of medicine | Pemazyre |
| INN | pemigatinib |
| Marketing-authorisation applicant | Incyte Biosciences Distribution B.V. |
| Therapeutic indication | Second-line treatment of advanced or metastatic cholangiocarcinoma characterized by fusion or rearrangements of fibroblast growth factor receptor 2 |
| More information | Pemazyre: Pending EC decision |
| Name of medicine | Seffalair Spiromax |
| INN | salmeterol / fluticasone |
| Marketing-authorisation applicant | Teva B.V. |
| Therapeutic indication | Treatment of asthma in adults and adolescents aged 12 years and older |
| More information | Seffalair Spiromax: Pending EC decision |
| Name of medicine | Sogroya |
| INN | somapacitan |
| Marketing-authorisation applicant | Novo Nordisk A/S |
| Therapeutic indication | Treatment of growth hormone deficiency in adults |
| More information | Sogroya: Pending EC decision |
| Name of medicine | Vazkepa |
| INN | icosapent ethyl |
| Marketing-authorisation applicant | Amarin Pharmaceuticals Ireland Limited |
| Therapeutic indication | Reduction of the risk of cardiovascular events in patients at high cardiovascular risk |
| More information | Vazkepa: Pending EC decision |
| Name of medicine | Alymsys |
| International non-proprietary name (INN) | bevacizumab |
| Marketing-authorisation applicant | Mabxience Research SL |
| 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 | Alymsys: Pending EC decision |
| Name of medicine | Oyavas |
| INN | bevacizumab |
| Marketing-authorisation applicant | STADA Arzneimittel AG |
| 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 | Oyavas: Pending EC decision |
| Name of medicine | Thiotepa Riemser |
| INN | thiotepa |
| Marketing-authorisation applicant | Riemser Pharma GmbH |
| Therapeutic indication | Conditioning treatment before haematopoietic progenitor cell transplantation |
| More information | Thiotepa Riemser: 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 | Sirturo |
| INN | bedaquiline |
| Marketing-authorisation holder | Janssen-Cilag International NV |
| More information | Sirturo: Pending EC decision |
| Name of medicine | Vaxchora |
| Common name | cholera vaccine, oral, live |
| Marketing-authorisation holder | Emergent Netherlands B.V. |
| More information | Vaxchora: Pending EC decision |
| Name of medicine | Tysabri |
| INN | natalizumab |
| Marketing-authorisation holder | Biogen Netherlands B.V. |
| More information | Tysabri: Pending EC decision |
| Name of medicine | Dexamethasone Taw |
| INN | dexamethasone phosphate |
| Marketing-authorisation applicant | Taw Pharma (Ireland) Ltd |
| More information | Dexamethasone Taw: Withdrawn application |
| Name of medicine | Tecentriq |
| INN | atezolizumab |
| Marketing-authorisation holder | Roche Registration GmbH |
| More information | Tecentriq: Withdrawn application |