Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2022
News
Human
COVID-19
Medicines
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Two applications for marketing authorisation were withdrawn: Orepaxam* for the treatment of pulmonary arterial hypertension, and Febseltiq* for the treatment of cholangiocarcinoma (cancer of the bile ducts).
Two applications for extensions of therapeutic indications were withdrawn: Gavreto for the treatment of certain types of thyroid cancer, and Ilaris for the treatment of Schnitzler syndrome, a rare inflammatory disease causing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.
*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 medicine | VidPrevtyn Beta |
| International non-proprietary name (INN) | COVID-19 vaccine (recombinant, adjuvanted) |
| Marketing-authorisation applicant | Sanofi Pasteur |
| Therapeutic indication | VidPrevtyn 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 medicine | Kauliv |
| INN | teriparatide |
| Marketing-authorisation applicant | Strides Pharma Cyprus |
| Therapeutic indication | Treatment of osteoporosis |
| More information | Kauliv: Pending EC decision |
Positive recommendations on new generic medicines
| Name of medicine | Pirfenidone Viatris |
| INN | pirfenidone |
| Marketing-authorisation applicant | Viatris Limited |
| Therapeutic indication | Treatment of idiopathic pulmonary fibrosis |
| More information | Pirfenidone Viatris: Pending EC decision |
| Name of medicine | Sugammadex Amomed |
| INN | sugammadex |
| Marketing-authorisation applicant | AOP Orphan Pharmaceuticals GmbH |
| Therapeutic indication | Reversal of neuromuscular blockade induced by rocuronium or vecuronium |
| More information | Sugammadex Amomed: Pending EC decision |
Positive recommendations on extensions of indications
| Name of medicine | Ceprotin |
| INN | human protein C |
| Marketing-authorisation holder | Takeda Manufacturing Austria AG |
| More information | Ceprotin: Pending EC decision |
| Name of medicine | Comirnaty |
| INN | tozinameran |
| Marketing-authorisation holder | BioNTech Manufacturing GmbH |
| More information | Comirnaty: Pending EC decision |
| Name of medicine | DuoPlavin |
| INN | clopidogrel / acetylsalicylic acid |
| Marketing-authorisation holder | Sanofi-aventis groupe |
| More information | DuoPlavin: Pending EC decision |
| Name of medicine | Dupixent |
| INN | dupilumab |
| Marketing-authorisation holder | Sanofi-aventis groupe |
| More information | Dupixent: Pending EC decision |
| Name of medicine | Enhertu |
| INN | trastuzumab deruxtecan |
| Marketing-authorisation holder | Daiichi Sankyo Europe GmbH |
| More information | Enhertu: Pending EC decision |
| Name of medicine | Eylea |
| INN | aflibercept |
| Marketing-authorisation holder | Bayer AG |
| More information | Eylea: Pending EC decision |
| Name of medicine | Imfinzi |
| INN | durvalumab |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Imfinzi: Pending EC decision |
| Name of medicine | Iscover |
| INN | clopidogrel |
| Marketing-authorisation holder | Sanofi-aventis groupe |
| More information | Iscover: Pending EC decision |
| Name of medicine | Lynparza |
| INN | olaparib |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Lynparza: Pending EC decision |
| Name of medicine | Plavix |
| INN | clopidogrel |
| Marketing-authorisation holder | Sanofi-aventis groupe |
| More information | Plavix: Pending EC decision |
| Name of medicine | Xofluza |
| INN | baloxavir marboxil |
| Marketing-authorisation holder | Roche Registration GmbH |
| More information | Xofluza: Pending EC decision |
| Name of medicine | Febseltiq |
| INN | infigratinib |
| Marketing-authorisation applicant | Helsinn Birex Pharmaceuticals Limited |
| More information | Febseltiq: Withdrawn application |
| Name of medicine | Orepaxam |
| INN | treprostinil diolamine |
| Marketing-authorisation applicant | Ferrer Internacional S.A. |
| More information | Orepaxam: Withdrawn application |
| Name of medicine | Gavreto |
| INN | pralsetinib |
| More information | Gavreto: Withdrawn application |
| Name of medicine | Ilaris |
| INN | canakinumab |
| More information | Ilaris: Withdrawn application |
Conclusion of referral
| Name of medicine | Janus kinase (JAK) inhibitors |
| More information | Janus Kinase inhibitors (JAKi) |