Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2023
NewsHumanCOVID-19MedicinesReferrals
14 new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2023 meeting.
The CHMP recommended granting a marketing authorisation for Abrysvo (bivalent, recombinant), a vaccine to protect small infants and older people against lower respiratory tract disease caused by respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild, cold-like symptoms that can be serious in vulnerable people, including older adults and those with lung or heart disease and diabetes. See more details in the news announcement in the grid below.
The Committee gave a positive opinion for Apretude (cabotegravir) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection. According to the World Health Organization (WHO), 39 million people were living with HIV worldwide at the end of 2022.
A positive opinion was adopted for Degarelix Accord (degarelix acetate), a generic medicine for the treatment of prostate cancer.
Enrylaze (crisantaspase) received a positive opinion from the CHMP for the treatment of acute lymphoblastic leukaemia, a type of blood cancer that starts from white blood cells called lymphocytes in the bone marrow, and lymphoblastic lymphoma, an aggressive type of non-Hodgkin lymphoma. Non-Hodgkin lymphoma is a cancer of the lymphatic system that can arise in lymph nodes or outside of the lymphatic system.
The CHMP recommended granting a marketing authorisation for Inaqovi (decitabine/cedazuridine) for the treatment of acute myeloid leukaemia, a disease in which cancer cells are found in the blood and the bone marrow.
The committee adopted a positive opinion for Litfulo (ritlecitinib) for the treatment of severe alopecia areata, a disease that causes hair loss on the scalp or other parts of the body.
Lyfnua (gefapixant), intended for the treatment of refractory or unexplained chronic cough, received a positive opinion from the committee.
The CHMP adopted a positive opinion for Orserdu (elacestrant) for the treatment of postmenopausal women and men with locally advanced or metastatic breast cancer.
The committee recommended granting a conditional marketing authorisation for Talvey* (talquetamab) for the treatment of adult patients with relapsed and refractory multiple myeloma, a rare cancer of the bone marrow that affects plasma cells, a type of white blood cell that produces antibodies. Talvey was supported through EMA's priority medicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support for medicines that have a particular potential to address patients' unmet medical needs.
A positive opinion was adopted for Tepkinly* (epcoritamab) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, a fast-growing cancer of the lymphatic system.
Tevimbra* (tislelizumab) received a positive opinion from the CHMP for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.
The committee adopted a positive opinion for Tyenne (tocilizumab), a biosimilar medicine intended for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19. Tyenne is the first biosimilar for this active substance.
The biosimilar medicine Tyruko (natalizumab) received a positive opinion as therapy for active relapsing remitting multiple sclerosis, a disease of the brain and spinal cord in which inflammation destroys the protective covering around nerves and the nerves themselves.
The CHMP adopted a positive opinion for Yesafili (aflibercept), a biosimilar treatment of age-related macular degeneration, affecting the central part of the retina at the back of the eye, and different types of visual impairment.
Negative opinion for a new medicine
The CHMP recommended the refusal of a marketing authorisation for Krazati (adagrasib) intended for the treatment of patients with advanced non-small cell lung cancer with a specific mutation, G12C, in the KRAS protein.
For more information on this negative opinion, see the question-and-answer document in the grid below.
Recommendations on extensions of therapeutic indication for 7 medicines
The committee recommended 7 extensions of indication for medicines that are already authorised in the European Union (EU): Bylvay*, Ervebo, Evrysdi*, Keytruda, Olumiant, Opdivo and Spikevax.
Withdrawals of applications
Three applications for marketing authorisation were withdrawn: Gefzuris, a duplicate of Lyfnua for the treatment of refractory or unexplained chronic cough, Jesduvroq for the treatment of adult patients with anaemia associated with chronic kidney disease, and Lagevrio, for the treatment of COVID-19. Question-and-answer documents are available in the grid below.
The marketing authorisation holder for Gazyvaro* withdrew an application to extend the therapeutic indication to include use of Gazyvaro as a pre-treatment to reduce the risk of cytokine release syndrome associated with Columvi (glofitamab), a cancer medicine. A question-and-answer document on the withdrawal is available in the grid below.
Start of referral
EMA has started a referral procedure triggered by the Agency of Medicines and Medical Devices (AEMPS) in Spain, concerning the contract research organisation (CRO) Synapse Labs Pvt. Ltd., located in Kharadi, Pune (India). For more information, see the public health communication in the grid below.
Agenda and minutes
The agenda of the July 2023 CHMP meeting is published on EMA's website. Minutes of the June 2023 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the July 2023 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.
1The information for Talvey was corrected on 30 August 2023 to reflect that the product has received a positive opinion for a conditional marketing authorisation (and not a full marketing authorisation as stated on 21 July 2023).
Positive recommendations on new medicines
| Name of medicine | Abrysvo |
|---|---|
| Common name | respiratory syncytial virus vaccine (bivalent, recombinant) |
| Marketing-authorisation applicant | Pfizer Europe MA EEIG |
| Therapeutic indication | Prevention of lower respiratory tract (LRT) disease |
| More information | News: First RSV vaccine to protect infants up to 6 months of age and older adults |
| Name of medicine | Apretude |
|---|---|
| International non-proprietary name (INN) | cabotegravir |
| Marketing-authorisation applicant | ViiV Healthcare B.V. |
| Therapeutic indication | Pre-exposure prophylaxis of HIV-1 infection |
| More information | Apretude: Pending EC decision |
| Name of medicine | Enrylaze |
|---|---|
| INN | crisantaspase |
| Marketing-authorisation applicant | Jazz Pharmaceuticals Ireland Limited |
| Therapeutic indication | Indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) |
| More information | Enrylaze: Pending EC decision |
| Name of medicine | Inaqovi |
|---|---|
| INN | decitabine / cedazuridine |
| Marketing-authorisation applicant | Otsuka Pharmaceutical Netherlands B.V. |
| Therapeutic indication | Treatment of myeloid leukaemia |
| More information | Inaqovi: Pending EC decision |
| Name of medicine | Litfulo |
|---|---|
| INN | ritlecitinib |
| Marketing-authorisation applicant | Pfizer Europe MA EEIG |
| Therapeutic indication | Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years of age and older |
| More information | Litfulo: Pending EC decision |
| Name of medicine | Lyfnua |
|---|---|
| INN | gefapixant |
| Marketing-authorisation applicant | Merck Sharp & Dohme B.V. |
| Therapeutic indication | Treatment of refractory or unexplained chronic cough |
| More information | Lyfnua: Pending EC decision |
| Name of medicine | Orserdu |
|---|---|
| INN | elacestrant |
| Marketing-authorisation applicant | Stemline Therapeutics B.V. |
| Therapeutic indication | Treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor |
| More information |
| Name of medicine | Talvey |
|---|---|
| INN | talquetamab |
| Marketing-authorisation applicant | Janssen-Cilag International N.V. |
| Therapeutic indication | Monotherapy treatment of adult patients with relapsed and refractory multiple myeloma |
| More information | Talvey: Pending EC decision |
| Name of medicine | Tepkinly |
|---|---|
| INN | epcoritamab |
| Marketing-authorisation applicant | AbbVie Deutschland GmbH & Co. KG |
| Therapeutic indication | Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) |
| More information | Tepkinly: Pending EC decision |
| Name of medicine | Tevimbra |
|---|---|
| INN | tislelizumab |
| Marketing-authorisation applicant | Novartis Europharm Limited |
| Therapeutic indication | Treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy |
| More information | Tevimbra: Pending EC decision |
Positive recommendation on new generic medicine
| Name of medicine | Degarelix Accord |
|---|---|
| INN | degarelix acetate |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of prostate cancer |
| More information | Degarelix Accord: Pending EC decision |
Positive recommendations on new biosimilar medicines
| Name of medicine | Tyenne |
|---|---|
| INN | tocilizumab |
| Marketing-authorisation applicant | Fresenius Kabi Deutschland GmbH |
| Therapeutic indication | Treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis (sJIA), juvenile idiopathic polyarthritis (pJIA), Giant Cell Arteritis (GCA), chimeric antigen receptor (CAR) T cell-induced cytokine release syndrome (CRS) and COVID-19 |
| More information | Tyenne: Pending EC decision |
| Name of medicine | Tyruko |
|---|---|
| INN | natalizumab |
| Marketing-authorisation applicant | Sandoz GmbH |
| Therapeutic indication | Therapy for active relapsing remitting multiple sclerosis (RRMS) |
| More information | Tyruko: Pending EC decision |
| Name of medicine | Yesafili |
|---|---|
| INN | aflibercept |
| Marketing-authorisation applicant | Viatris Limited |
| Therapeutic indication | Treatment of age-related macular degeneration (AMD) and visual impairment |
| More information | Yesafili: Pending EC decision |
Negative recommendations on new medicines
| Name of medicine | Krazati |
|---|---|
| INN | adagrasib |
| Marketing-authorisation applicant | Mirati Therapeutics B.V. |
| Therapeutic indication | Treatment of patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation |
| More information | Krazati: Pending EC decision |
Positive recommendations on extensions of indications
| Name of medicine | Bylvay |
|---|---|
| INN | odevixibat |
| Marketing-authorisation holder | Albireo |
| More information | Bylvay: Pending EC decision |
| Name of medicine | Ervebo |
|---|---|
| INN | recombinant vesicular stomatitis virus |
| Marketing-authorisation holder | Merck & Co. |
| More information | Ervebo: Pending EC decision |
| Name of medicine | Evrysdi |
|---|---|
| INN | risdiplam |
| Marketing-authorisation holder | Roche Registration GmbH |
| More information | Evrysdi: Pending EC decision |
| Name of medicine | Keytruda |
|---|---|
| INN | pembrolizumab |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information | Keytruda: Pending EC decision |
| Name of medicine | Olumiant |
|---|---|
| INN | baricitinib |
| Marketing-authorisation holder | Eli Lilly Nederland B.V. |
| More information |
| Name of medicine | Opdivo |
|---|---|
| INN | nivolumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information |
| Name of medicine | Spikevax |
|---|---|
| INN | COVID-19 mRNA vaccine (nucleoside-modified) |
| Marketing-authorisation holder | Moderna Biotech Spain, S.L. |
| More information |
| Name of medicine | Gefzuris |
|---|---|
| INN | gefapixant |
| Marketing-authorisation applicant | Merck Sharp & Dohme B.V. |
| More information | This application was a duplicate of Lyfnua |
| Name of medicine | Jesduvroq |
|---|---|
| INN | daprodustat |
| Marketing-authorisation applicant | Glaxosmithkline Trading Services Limited; treatment of anaemia associated with chronic kidney disease (CKD) in adults |
| More information | Questions and answsers on Jesduvroq |
| Name of medicine | Lagevrio |
|---|---|
| INN | molnupiravir |
| Marketing-authorisation applicant | Merck Sharp & Dohme B.V. |
| More information | Questions and answsers on Lagevrio |
| Name of medicine | Gazyvaro |
|---|---|
| INN | obinutuzumab |
Marketing-authorisation holder | Roche Registration GmbH |
| More information | Questions and answsers on Gazyvaro |
Start of referral
| Name of medicine | Synapse Labs Pvt. Ltd. |
|---|---|
Marketing-authorisation holder | Various companies |
| More information | Synapse |