Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021

News 17/12/2021

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.

CHMP highlights Dec 2021

Positive recommendations on new medicines

Name of medicineApexxnar
Common namepneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indicationProphylaxis against pneumococcal pneumonia and associated invasive disease
More informationApexxnar: Pending EC decision

 

Name of medicineKerendia
INNfinerenone
Marketing-authorisation applicantBayer AG
Therapeutic indicationTreatment of chronic kidney disease associated with type 2 diabetes in adults
More informationKerendia: Pending EC decision

 

Name of medicineNgenla
INNsomatrogon
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indicationTreatment of growth hormone deficiency in children and adolescents from 3 years of age
More informationNgenla: Pending EC decision

 

Name of medicineOxbryta
INNvoxelotor
Marketing-authorisation applicantGlobal Blood Therapeutics Netherlands
Therapeutic indicationTreatment of haemolytic anaemia due to sickle cell disease
More information

Oxbryta: Pending EC decision

News announcement: New treatment for sickle cell disease

 

Name of medicinePadcev
INNenfortumab vedotin
Marketing-authorisation applicantAstellas Pharma Europe B.V.
Therapeutic indicationTreatment of adult patients with urothelial cancer
More informationPadcev: Pending EC decision

 

Name of medicineSaphnelo
INNanifrolumab
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationTreatment of moderate to severe systemic lupus erythematosus
More informationSaphnelo: Pending EC decision

 

Name of medicineTepmetko
INNtepotinib
Marketing-authorisation applicantMerck Europe B.V.
Therapeutic indicationTreatment of patients with advanced non-small cell lung cancer
More informationTepmetko: Pending EC decision

 

Name of medicineXevudy
INNsotrovimab
Marketing-authorisation applicantGlaxoSmithKline
Therapeutic indicationTreatment of COVID-19
More information

News announcement:  COVID-19: EMA recommends authorisation of antibody medicine Xevudy

 

Name of medicineYselty
INNlinzagolix choline
Marketing-authorisation applicantObsEva Ireland Ltd
Therapeutic indicationTreatment of symptoms of uterine fibroids
More informationYselty: Pending EC decision

 

Positive recommendations on new generic medicines

Name of medicineSapropterin Dipharma
INNsapropterin
Marketing-authorisation applicantDipharma B.V.
Therapeutic indicationTreatment of hyperphenylalaninemia
More informationSapropterin Dipharma: Pending EC decision

 

Name of medicineSitagliptin/Metformin hydrochloride Mylan
INNsitagliptin hydrochloride monohydrate / metformin hydrochloride
Marketing-authorisation applicantMylan Ireland Limited
Therapeutic indicationTreatment of type 2 diabetes mellitus
More informationSitagliptin / Metformin hydrochloride Mylan: Pending EC decision

 

Positive recommendation on a new informed-consent medicine

Name of medicineOntilyv
INNopicapone
Marketing-authorisation applicantBial Portela & Companhia S.A.
Therapeutic indicationTreatment of Parkinson’s disease
More informationOntilyv: Pending EC decision

 

Positive recommendation on a new hybrid medicine

Name of medicineOkedi
INNrisperidone
Marketing-authorisation applicantLaboratorios Farmacéuticos Rovi, S.A.
Therapeutic indicationTreatment of schizophrenia in adults
More informationOkedi: Pending EC decision

 

Negative recommendation on a new medicine

Name of medicineAduhelm
INNaducanumab
Marketing-authorisation applicantBiogen Netherlands B.V.
Therapeutic indicationTreatment of Alzheimer’s disease
More informationAduhelm: Pending EC decision

 

Withdrawal of initial marketing authorisation application

Name of medicineZektayos-Hepjuvo
INNobeticholic acid
More informationZektayos - Hepjuvo: Withdrawn application

 

Positive recommendations on new therapeutic indications

Name of medicineEntyvio
INNvedolizumab
Marketing-authorisation holderTakeda Pharma A/S
More informationEntyvio: Pending EC decision

 

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

 

Name of medicineKineret
INNanakinra
Marketing-authorisation holderSwedish Orphan Biovitrum AB (publ)
More information

News announcement: EMA recommends approval for use of Kineret in adults with COVID-19

 

Name of medicineLorviqua
INNlorlatinib
Marketing-authorisation holderPfizer Europe MA EEIG
More informationLorviqua: Pending EC decision

 

Name of medicineTeysuno
INNtegafur / gimeracil / oteracil
Marketing-authorisation holderNordic Group B.V.
More informationTeysuno: Pending EC decision

 

Name of medicineVeklury
INNremdesivir
Marketing-authorisation holderGilead Sciences Ireland UC
More information

 

Opinions on any scientific matter (Article 5(3))

Name of medicinePaxlovid
INNPF-07321332 / ritonavir
Marketing-authorisation holderPfizer Europe MA EEIG
More informationNews announcement: EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel

 

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