Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022

News 11/11/2022

Four new medicines recommended for approval

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

The CHMP recommended authorising the COVID-19 vaccine VidPrevtyn Beta (COVID-19 vaccine (recombinant, adjuvanted)) as a booster in adults previously vaccinated with an mRNA or adenoviral vector COVID-19 vaccine. It is the seventh vaccine recommended in the European Union (EU) for protecting against COVID-19 and, together with the vaccines already authorised, will support vaccination campaigns in EU Member States during the pandemic. See more information in the news announcement in the grid below.

The committee adopted a positive opinion for a biosimilar medicine, Kauliv (teriparatide), for the treatment of osteoporosis, a health condition that weakens bones, making them fragile and more likely to break.

A generic medicine, Pirfenidone Viatris (pirfenidone), received a positive opinion for the treatment of idiopathic pulmonary fibrosis, a chronic and progressive condition in which the lungs become scarred and breathing becomes increasingly difficult.

The CHMP adopted a positive opinion for a generic medicine, Sugammadex Amomed (sugammadex), intended for the reversal of neuromuscular blockade induced by rocuronium in adults and children or vecuronium in adults. Rocuronium and vecuronium are muscle relaxants used during some types of surgeries. Sugammadex is used to speed up the recovery from the effects of the muscle relaxant.

Recommendations on extensions of therapeutic indication for 11 medicines

The committee recommended 11 extensions of indication for medicines that are already authorised in the EU: Ceprotin, Comirnaty, DuoPlavin, Dupixent, Enhertu, Eylea, Imfinzi, Iscover, Lynparza, Plavix and Xofluza.

Withdrawals of applications

Two applications for marketing authorisation were withdrawn: Orepaxam* for the treatment of pulmonary arterial hypertension, and Febseltiq* for the treatment of cholangiocarcinoma (cancer of the bile ducts).

Two applications for extensions of therapeutic indications were withdrawn: Gavreto for the treatment of certain types of thyroid cancer, and Ilaris for the treatment of Schnitzler syndrome, a rare inflammatory disease causing long-term urticaria, recurrent fever, bone and joint pain, and swollen lymph nodes.

Question-and-answer documents on the withdrawals are available in the grid below.

COVID-19 update

The committee recommended extending the use of COVID-19 vaccine Comirnaty targeting the original strain and Omicron subvariants BA.4 and BA.5 in children between 5 to 11 years of age.

An overview of all the COVID-19 vaccines authorised in the EU is available on EMA’s website.

Safety update

The CHMP endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risk of serious side effects with Janus kinase (JAK) inhibitors used to treat several chronic inflammatory disorders. These side effects include cardiovascular conditions, blood clots, cancer and serious infections. This recommendation is the outcome of an article 20 referral procedure, which is triggered for medicines that have been authorised via the centralised procedure in case of quality, safety or efficacy issues. A public health communication on this referral is available in the grid below.

Agenda and minutes

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

CHMP statistics

Key figures from the November 2022 CHMP meeting are represented in the graphic below.

CHMP highlights - November 2022

*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 recommendation on new medicines

Name of medicineVidPrevtyn Beta
International non-proprietary name (INN)COVID-19 vaccine (recombinant, adjuvanted)
Marketing-authorisation applicantSanofi Pasteur
Therapeutic indicationVidPrevtyn Beta is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received a mRNA or adenoviral vector COVID-19 vaccine
More information

VidPrevtyn Beta: Pending EC decision

News announcement:EMA recommends approval of VidPrevtyn Beta as a COVID 19 booster vaccine


Positive recommendation on new biosimilar medicine

Name of medicineKauliv
Marketing-authorisation applicantStrides Pharma Cyprus
Therapeutic indicationTreatment of osteoporosis
More informationKauliv: Pending EC decision


Positive recommendations on new generic medicines

Name of medicinePirfenidone Viatris
Marketing-authorisation applicantViatris Limited
Therapeutic indicationTreatment of idiopathic pulmonary fibrosis
More informationPirfenidone Viatris: Pending EC decision


Name of medicineSugammadex Amomed
Marketing-authorisation applicantAOP Orphan Pharmaceuticals GmbH
Therapeutic indicationReversal of neuromuscular blockade induced by rocuronium or vecuronium
More informationSugammadex Amomed: Pending EC decision


Positive recommendations on extensions of indications

Name of medicineCeprotin
INNhuman protein C
Marketing-authorisation holderTakeda Manufacturing Austria AG
More informationCeprotin: Pending EC decision


Name of medicineComirnaty
Marketing-authorisation holderBioNTech Manufacturing GmbH
More informationComirnaty: Pending EC decision


Name of medicineDuoPlavin
INNclopidogrel / acetylsalicylic acid
Marketing-authorisation holderSanofi-aventis groupe
More informationDuoPlavin: Pending EC decision


Name of medicineDupixent
Marketing-authorisation holderSanofi-aventis groupe
More informationDupixent: Pending EC decision


Name of medicineEnhertu
INNtrastuzumab deruxtecan
Marketing-authorisation holderDaiichi Sankyo Europe GmbH
More informationEnhertu: Pending EC decision


Name of medicineEylea
Marketing-authorisation holderBayer AG
More informationEylea: Pending EC decision


Name of medicineImfinzi
Marketing-authorisation holderAstraZeneca AB
More informationImfinzi: Pending EC decision


Name of medicineIscover
Marketing-authorisation holderSanofi-aventis groupe
More informationIscover: Pending EC decision


Name of medicineLynparza
Marketing-authorisation holderAstraZeneca AB
More informationLynparza: Pending EC decision


Name of medicinePlavix
Marketing-authorisation holderSanofi-aventis groupe
More informationPlavix: Pending EC decision


Name of medicineXofluza
INNbaloxavir marboxil
Marketing-authorisation holderRoche Registration GmbH
More informationXofluza: Pending EC decision


Withdrawal of initial marketing authorisation application

Name of medicineFebseltiq
Marketing-authorisation applicantHelsinn Birex Pharmaceuticals Limited
More informationFebseltiq: Withdrawn application


Name of medicineOrepaxam
INNtreprostinil diolamine
Marketing-authorisation applicantFerrer Internacional S.A.
More informationOrepaxam: Withdrawn application


Withdrawals of post-authorisation marketing authorisation applications

Name of medicineGavreto
More informationGavreto: Withdrawn application


Name of medicineIlaris
More informationIlaris: Withdrawn application


Conclusion of referral

Name of medicineJanus kinase (JAK) inhibitors
More informationJanus kinase inhibitors (JAKi)


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