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
VidPrevtynBeta
(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were withdrawn: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were withdrawn: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 ofquality, 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-authorisationholder
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-authorisationholder
Sanofi-aventis groupe
More information
Iscover: Pending EC decision
Name of medicine
Lynparza
INN
olaparib
Marketing-authorisationholder
AstraZeneca AB
More information
Lynparza: Pending EC decision
Name of medicine
Plavix
INN
clopidogrel
Marketing-authorisationholder
Sanofi-aventis groupe
More information
Plavix: Pending EC decision
Name of medicine
Xofluza
INN
baloxavir marboxil
Marketing-authorisationholder
Roche Registration GmbH
More information
Xofluza: Pending EC decision
Withdrawal of initial marketing authorisation application
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-authorisationapplicant
Ferrer Internacional S.A.
More information
Orepaxam: Withdrawn application
Withdrawals of post-authorisation marketing authorisation applications
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)
Other updates
List item
Scientific advice and protocol assistance adopted during the CHMP meeting 7-10 November 2022
(PDF/246.92 KB)
(new)
Adopted
First published: 11/11/2022
EMA/CHMP/SAWP/872304/2022
List item
Start of Union reviews adopted during the CHMP meeting of 7-10 November 2022
(PDF/106.5 KB)
(new)
Adopted
First published: 11/11/2022
EMA/846051/2022