Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 March 2022

News 25/03/2022

Five new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2022 meeting.

The monoclonal antibody Evusheld (tixagevimab / cilgavimab) received a positive opinion from the CHMP for the prevention of COVID-19. More details are available in a separate news announcement.

A new gene therapy, Carvykti* (ciltacabtagene autoleucel), received a positive opinion for a conditional marketing authorisation for the treatment of multiple myeloma. Carvykti had support through the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. See more details in the news announcement in the grid below.

Two medicines were submitted in hybrid applications, which means they 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: Camcevi (leuprorelin) for the treatment of hormone-dependent prostate cancer and Zolsketil pegylated liposomal (doxorubicin) for the treatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma.

A generic medicine, Amifampridine SERB (amifampridine), received a positive opinion from the Committee for the treatment of Lambert-Eaton myasthenic syndrome.

Recommendations on extensions of therapeutic indication for five medicines

The Committee recommended six extensions of indication for medicines that are already authorised in the European Union (EU): Cabometyx, Jakavi, Keytruda (for which there were two extensions), Kymriah* and Polivy*.

Withdrawals of application

The application for a marketing authorisation for Dimherity (dimethyl fumarate) was withdrawn. Dimherity was intended for the treatment of adult patients with relapsing remitting multiple sclerosis.

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

Other updates

Concluding a review of an application to extend the use of Vyxeos liposomal* (daunorubicin / cytarabine), the CHMP did not recommend including the treatment of young patients (aged 1 to 21 years) with acute myeloid leukaemia (AML) to the authorised indications. The Committee agreed that relevant data from the study submitted with the application should be included in the medicine’s product information so that healthcare professionals have access to up-to-date data on the effects of Vyxeos liposomal in patients with relapsing or refractory AML.

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

COVID-19 update

An increase in manufacturing capacity for COVID-19 vaccine Comirnaty was approved by the CHMP.

Agenda and minutes

The agenda of the March 2022 CHMP meeting is published on EMA's website. Minutes of the February 2022 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the March 2022 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: March 2022

Positive recommendations on new medicines

Name of medicineCarvykti
International non-proprietary name (INN)ciltacabtagene autoleucel 
Marketing-authorisation applicantJanssen-Cilag International NV
Therapeutic indicationTreatment of multiple myeloma
More information

Carvykti: Pending EC decision
 

News announcement: New gene therapy to treat adult patients with multiple myeloma

Name of medicineEvusheld
INNtixagevimab / cilgavimab
Marketing-authorisation applicantAstraZeneca AB
Therapeutic indicationPrevention of COVID-19
More information

Evusheld: Pending EC decision
 

News announcement: EMA recommends authorisation of COVID-19 medicine Evusheld

 

Positive recommendations on new hybrid medicines

Name of medicineCamcevi
INNleuprorelin
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of hormone-dependent prostate cancer
More informationCamcevi: Pending EC decision

 

Name of medicineZolsketil pegylated liposomal 
INNdoxorubicin
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of breast cancer, ovarian cancer, progressive multiple myeloma and AIDS-related Kaposi's sarcoma
More informationZolsketil pegylated liposomal: Pending EC decision

 

Positive recommendations on new generic medicine

Name of medicineAmifampridine SERB
INNamifampridine
Marketing-authorisation applicantSERB SA
Therapeutic indicationTreatment of Lambert-Eaton myasthenic syndrome
More informationAmifampridine SERB: Pending EC decision

 

Positive recommendations on extensions of indications

Name of medicineCabometyx
INNcabozantinib 
Marketing-authorisation holderIpsen Pharma
More informationCabometyx: Pending EC decision

 

Name of medicineJakavi
INNruxolitinib
Marketing-authorisation holderNovartis Europharm Limited
More informationJakavi: Pending EC decision

 

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation holderMerck Sharp & Dohme B.V.
More information

Keytruda: Pending EC decision

Name of medicineKymriah 
INNtisagenlecleucel
Marketing-authorisation holderNovartis Europharm Limited
More informationKymriah: Pending EC decision

 

Name of medicinePolivy
INNpolatuzumab vedotin
Marketing-authorisation holderRoche Registration GmbH
More informationPolivy: Pending EC decision

 

Withdrawal of initial marketing authorisation application

Name of medicineDimherity
INNdimethyl fumarate
Marketing-authorisation holderSandoz GmbH
Therapeutic indicationTreatment of multiple sclerosis
More informationDimherity: Questions and answers

 

Other updates

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