Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021
NewsHumanCOVID-19Medicines
EMA’s human medicines committee (CHMP) recommended thirteen medicines for approval at its December 2021 meeting.
The monoclonal antibody Xevudy (sotrovimab) received a positive opinion from the Committee for the treatment of COVID-19. More details are available in a separate news announcement.
Oxbryta* (voxelotor) was granted a positive opinion for the treatment of haemolytic anaemia due to sickle cell disease. Oxbryta was supported through EMA’s Priority Medicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for promising medicines with a potential to address unmet medical needs. See more details in the news announcement in the grid below.
A positive opinion was adopted for Ngenla* (somatrogon) to treat growth hormone deficiency in adolescents and children from 3 years of age.
The CHMP gave a positive opinion for Apexxnar (pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)) as prophylaxis against pneumococcal pneumonia and associated invasive disease.
Kerendia (finerenone) was granted a positive opinion for treatment of chronic kidney disease associated with type 2 diabetes in adults.
The Committee gave a positive opinion for Padcev (enfortumab vedotin) to treat adult patients with urothelial cancer.
A positive opinion was granted to Saphnelo (anifrolumab) for the treatment of moderate to severe systemic lupus erythematosus.
The CHMP gave a positive opinion for Tepmetko (tepotinib) for the treatment of patients with advanced non-small cell lung cancer.
Yselty (linzagolix choline) was granted a positive opinion for the treatment of symptoms of uterine fibroids.
The CHMP recommended granting a marketing authorisation for Okedi (risperidone), intended for the treatment of schizophrenia in adults. Okedi was submitted in a hybrid application, which means it relied in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.
Two generic medicines received a positive opinion from the Committee: Sitagliptin/Metformin hydrochloride Mylan (sitagliptin hydrochloride monohydrate / metformin hydrochloride) for the treatment of type 2 diabetes mellitus and Sapropterin Dipharma (sapropterin) for the treatment of hyperphenylalaninemia.
The CHMP granted a positive opinion for one informed consent application for the treatment of Parkinson’s disease: Ontilyv (opicapone). An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.
Negative recommendation on a new medicine
The CHMP adopted a negative opinion refusing a marketing authorisation for Aduhelm (aducanumab). The medicine was intended for the treatment of Alzheimer’s disease.
For more information on this negative opinion, see the question-and-answer document in the grid below.
Recommendations on extensions of therapeutic indication for six medicines
Two medicines received a positive opinion from the Committee to extend their indications in relation to the treatment of COVID-19:
Kineret (anakinra) is an immunosuppressive medicine that is already authorised in the EU for the treatment of various inflammatory conditions. The CHMP recommended adding the treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure to its approved indications. More details on Kineret are available in a separate news announcement.
Veklury (remdesivir), an antiviral medicine, has been authorised for the treatment of patients with COVID-19 who have pneumonia and require supplemental oxygen since July 2020. The CHMP recommended including the treatment of adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 to its indication.
The Committee also recommended extensions of indication for Entyvio, Keytruda, Lorviqua and Teysuno.
COVID-19: Advice on use of Paxlovid for treating COVID-19
The CHMP issued advice on the use of the antiviral Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19. In parallel, a more comprehensive rolling review started on 13 December 2021, ahead of a possible application for a marketing authorisation. More details are available in a separate news announcement.
Withdrawal of an application
The application for a marketing authorisation for Zektayos-Hepjuvo (obeticholic acid) was withdrawn. Zektayos-Hepjuvo was intended for the treatment of non-alcoholic steatohepatitis with fibrosis (scarring), a form of liver inflammation unrelated to alcohol consumption.
A question-and-answer document on the withdrawal is available in the grid below.
COVID-19: Other updates
The Committee concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at least two months after the first dose in people aged 18 years and above. More details are available in a separate news announcement.
An increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer was approved by the CHMP. More details are available in a separate news announcement.
The CHMP will hold an extraordinary meeting on Monday, 20 December to discuss the marketing authorisation application for Novavax’s COVID-19 vaccine Nuvaxovid (also known as NVX-CoV2373).
Agenda and minutes
The agenda of the December 2021 CHMP meeting is published on EMA's website. Minutes of the November 2021 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the December 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.
Positive recommendations on new medicines
| Name of medicine | Apexxnar |
| Common name | pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) |
| Marketing-authorisation applicant | Pfizer Europe MA EEIG |
| Therapeutic indication | Prophylaxis against pneumococcal pneumonia and associated invasive disease |
| More information | Apexxnar: Pending EC decision |
| Name of medicine | Kerendia |
| INN | finerenone |
| Marketing-authorisation applicant | Bayer AG |
| Therapeutic indication | Treatment of chronic kidney disease associated with type 2 diabetes in adults |
| More information | Kerendia: Pending EC decision |
| Name of medicine | Ngenla |
| INN | somatrogon |
| Marketing-authorisation applicant | Pfizer Europe MA EEIG |
| Therapeutic indication | Treatment of growth hormone deficiency in children and adolescents from 3 years of age |
| More information | Ngenla: Pending EC decision |
| Name of medicine | Oxbryta |
| INN | voxelotor |
| Marketing-authorisation applicant | Global Blood Therapeutics Netherlands |
| Therapeutic indication | Treatment of haemolytic anaemia due to sickle cell disease |
| More information | News announcement:New treatment for sickle cell disease |
| Name of medicine | Padcev |
| INN | enfortumab vedotin |
| Marketing-authorisation applicant | Astellas Pharma Europe B.V. |
| Therapeutic indication | Treatment of adult patients with urothelial cancer |
| More information | Padcev: Pending EC decision |
| Name of medicine | Saphnelo |
| INN | anifrolumab |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Treatment of moderate to severe systemic lupus erythematosus |
| More information | Saphnelo: Pending EC decision |
| Name of medicine | Tepmetko |
| INN | tepotinib |
| Marketing-authorisation applicant | Merck Europe B.V. |
| Therapeutic indication | Treatment of patients with advanced non-small cell lung cancer |
| More information | Tepmetko: Pending EC decision |
| Name of medicine | Xevudy |
| INN | sotrovimab |
| Marketing-authorisation applicant | GlaxoSmithKline |
| Therapeutic indication | Treatment of COVID-19 |
| More information | News announcement:COVID-19: EMA recommends authorisation of antibody medicine Xevudy |
| Name of medicine | Yselty |
| INN | linzagolix choline |
| Marketing-authorisation applicant | ObsEva Ireland Ltd |
| Therapeutic indication | Treatment of symptoms of uterine fibroids |
| More information | Yselty: Pending EC decision |
Positive recommendations on new generic medicines
| Name of medicine | Sapropterin Dipharma |
| INN | sapropterin |
| Marketing-authorisation applicant | Dipharma B.V. |
| Therapeutic indication | Treatment of hyperphenylalaninemia |
| More information | Sapropterin Dipharma: Pending EC decision |
| Name of medicine | Sitagliptin/Metformin hydrochloride Mylan |
| INN | sitagliptin hydrochloride monohydrate / metformin hydrochloride |
| Marketing-authorisation applicant | Mylan Ireland Limited |
| Therapeutic indication | Treatment of type 2 diabetes mellitus |
| More information | Sitagliptin/Metformin hydrochloride Mylan: Pending EC decision |
Positive recommendation on a new informed-consent medicine
| Name of medicine | Ontilyv |
| INN | opicapone |
| Marketing-authorisation applicant | Bial Portela & Companhia S.A. |
| Therapeutic indication | Treatment of Parkinson’s disease |
| More information | Ontilyv: Pending EC decision |
Positive recommendation on a new hybrid medicine
| Name of medicine | Okedi |
| INN | risperidone |
| Marketing-authorisation applicant | Laboratorios Farmacéuticos Rovi, S.A. |
| Therapeutic indication | Treatment of schizophrenia in adults |
| More information | Okedi: Pending EC decision |
Negative recommendation on a new medicine
| Name of medicine | Aduhelm |
| INN | aducanumab |
| Marketing-authorisation applicant | Biogen Netherlands B.V. |
| Therapeutic indication | Treatment of Alzheimer’s disease |
| More information | Aduhelm: Pending EC decision |
| Name of medicine | Zektayos-Hepjuvo |
| INN | obeticholic acid |
| More information | Zektayos - Hepjuvo: Withdrawn application |
Positive recommendations on new therapeutic indications
| Name of medicine | Entyvio |
| INN | vedolizumab |
| Marketing-authorisation holder | Takeda Pharma A/S |
| More information | Entyvio: 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 | Kineret |
| INN | anakinra |
| Marketing-authorisation holder | Swedish Orphan Biovitrum AB (publ) |
| More information | News announcement:EMA recommends approval for use of Kineret in adults with COVID-19 |
| Name of medicine | Lorviqua |
| INN | lorlatinib |
| Marketing-authorisation holder | Pfizer Europe MA EEIG |
| More information | Lorviqua: Pending EC decision |
| Name of medicine | Teysuno |
| INN | tegafur / gimeracil / oteracil |
| Marketing-authorisation holder | Nordic Group B.V. |
| More information | Teysuno: Pending EC decision |
| Name of medicine | Veklury |
| INN | remdesivir |
| Marketing-authorisation holder | Gilead Sciences Ireland UC |
| More information | Veklury: Pending EC decision |
Opinions on any scientific matter (Article 5(3))
| Name of medicine | Paxlovid |
| INN | PF-07321332 / ritonavir |
| Marketing-authorisation holder | Pfizer Europe MA EEIG |
| More information | News announcement:EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19 |