Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 June 2022
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Nine new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its June 2022 meeting.
The CHMP recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in people from 18 to 50 years of age as primary vaccination. It is the sixth 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 Pepaxti* (melphalan flufenamide) for the treatment of multiple myeloma, a rare cancer of the bone marrow that affects plasma cells, a type of white blood cell that produces antibodies.
Rayvow (lasmiditan), intended for the treatment of migraine in adults, received a positive opinion from the CHMP. It is estimated that approximately 15% of the EU population suffers from migraine.
The CHMP recommended granting a conditional marketing authorisation for Roctavian* (valoctocogene roxaparvovec), the first gene therapy to treat severe haemophilia A, a rare inherited bleeding disorder caused by lack of factor VIII. Roctavian was supported through EMA's PRIority MEdicines (PRIME) scheme, which provides early and enhanced scientific and regulatory support to medicines that have a particular potential to address patients' unmet medical needs. See more information in the news announcement in the grid below.
The committee adopted a positive opinion for Scemblix* (asciminib), for the treatment of adults with Philadelphia chromosome?positive chronic myeloid leukaemia in chronic phase (Ph+CML?CP), previously treated with two or more tyrosine kinase inhibitors. This is a new therapeutic option for patients with this type of rare blood cancer.
The CHMP gave a positive opinion for Sunlenca (lenacapavir), intended for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults with multidrug?resistant HIV?1 infection.
Vyvgart* (efgartigimod alfa), intended for the treatment of anti?acetylcholine receptor (AChR) antibody positive generalised myasthenia gravis, received a positive opinion from the committee. Myasthenia gravis is a chronic autoimmune neuromuscular condition that causes muscle weakness in different parts of the body.
The CHMP gave a positive opinion for the biosimilar medicine Vegzelma (bevacizumab), intended for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.
The biosimilar medicine Ranivisio (ranibizumab) received a positive opinion for the treatment of adults with neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema or choroidal neovascularisation, and proliferative diabetic retinopathy.
Recommendations on extensions of therapeutic indication for eight medicines
The Committee recommended eight extensions of indication for medicines that are already authorised in the EU: Crysvita, Enhertu, Imbruvica, Lonquex, Lynparza, Rinvoq and Zerbaxa. It also includes an extension of the use of the COVID-19 vaccine Nuvaxovid in adolescents from 12-17 years of age. More information on this extension of indication is available in the news announcement in the grid below.
Re-examination of recommendations
The applicant for Tuznue and Hervelous has requested a re-examination of the Committee’s negative opinion for these medicines adopted at its May 2022 meeting. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.
A group of companies that contracted Synchron Research Services has requested a re-examination of EMA’s May 2022 opinion. Upon receipt of the grounds of the request, the Agency will re-examine its opinion and issue a final recommendation.
Agenda and minutes
The agenda of the June 2022 CHMP meeting is published on EMA's website. Minutes of the May 2022 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the June 2022 CHMP meeting are represented in the graphic below.
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*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 recommendations on new medicines
| Name of medicine | COVID-19 Vaccine (inactivated, adjuvanted) Valneva |
| Common name | COVID-19 vaccine (inactivated, adjuvanted, adsorbed) |
| Marketing-authorisation applicant | Valneva Austria GmbH |
| Therapeutic indication | Active immunisation against coronavirus disease 2019 (COVID-19) |
| More information | COVID-19 Vaccine (inactivated, adjuvanted) Valneva: Pending EC decision
News announcement:EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU |
| Name of medicine | Pepaxti |
| INN | melphalan flufenamide |
| Marketing-authorisation applicant | Oncopeptides AB |
| Therapeutic indication | Treatment of multiple myeloma |
| More information | Pepaxti: Pending EC decision |
| Name of medicine | Rayvow |
| International non-proprietary name (INN) | lasmiditan |
| Marketing-authorisation applicant | Eli Lilly Nederland B.V. |
| Therapeutic indication | Treatment of migraine |
| More information | Rayvow: Pending EC decision |
| Name of medicine | Roctavian |
| INN | valoctocogene roxaparvovec |
| Marketing-authorisation applicant | BioMarin International Limited |
| Therapeutic indication | Treatment of severe haemophilia A |
| More information | Roctavian: Pending EC decision
News announcement:First gene therapy to treat severe haemophilia A |
| Name of medicine | Scemblix |
| INN | asciminib |
| Marketing-authorisation applicant | Novartis Europharm Limited |
| Therapeutic indication | Treatment of Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+CML-CP) |
| More information | Scemblix: Pending EC decision |
| Name of medicine | Sunlenca |
| INN | lenacapavir |
| Marketing-authorisation applicant | Gilead Sciences Ireland Unlimited Company |
| Therapeutic indication | Treatment of human immunodeficiency virus type 1 (HIV-1) infection |
| More information | Sunlenca: Pending EC decision |
| Name of medicine | Vyvgart |
| INN | efgartigimod alfa |
| Marketing-authorisation applicant | Argenx |
| Therapeutic indication | Treatment of anti acetylcholine receptor (AChR) antibody positive generalised myasthenia gravis |
| More information | Vyvgart: Pending EC decision |
Positive recommendations on new biosimilar medicines
| Name of medicine | Ranivisio |
| INN | ranibizumab |
| Marketing-authorisation applicant | Midas Pharma GmbH |
| Therapeutic indication | Treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema or choroidal neovascularisation, and proliferative diabetic retinopathy |
| More information | Ranivisio: Pending EC decision |
| Name of medicine | Vegzelma |
| INN | bevacizumab |
| Marketing-authorisation applicant | Celltrion Healthcare Hungary Kft |
| Therapeutic indication | Treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix |
| More information | Vegzelma: Pending EC decision |
Re-examination of recommendations for new medicines
| Name of medicine | Hervelous |
| INN | trastuzumab |
| Marketing-authorisation applicant | Prestige Biopharma Belgium |
| Therapeutic indication | Treatment of certain forms of breast cancer and gastric (stomach) cancer |
| More information | Hervelous: Pending EC decision |
| Name of medicine | Tuznue |
| INN | trastuzumab |
| Marketing-authorisation applicant | Prestige Biopharma Belgium |
| Therapeutic indication | Treatment of certain forms of breast cancer and gastric (stomach) cancer |
| More information | Tuznue: Pending EC decision |
Positive recommendations on extensions of indications
| Name of medicine | Crysvita |
| INN | burosumab |
| Marketing-authorisation holder | Kyowa Kirin Holdings B.V. |
| More information | Crysvita: 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 | Imbruvica |
| INN | ibrutinib |
| Marketing-authorisation holder | Janssen-Cilag International NV |
| More information | Imbruvica: Pending EC decision |
| Name of medicine | Lonquex |
| INN | lipegfilgrastim |
| Marketing-authorisation holder | Teva B.V. |
| More information | Lonquex: Pending EC decision |
| Name of medicine | Lynparza |
| INN | olaparib |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Lynparza: Pending EC decision |
| Name of medicine | Nuvaxovid |
| Common name | COVID-19 Vaccine (recombinant, adjuvanted) |
| Marketing-authorisation holder | Novavax CZ, a.s. |
| More information | Nuvaxovid: Pending EC decision
News announcement:EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17 |
| Name of medicine | Rinvoq |
| INN | upadacitinib |
| Marketing-authorisation holder | AbbVie Deutschland GmbH & Co. KG |
| More information | Rinvoq: Pending EC decision |
| Name of medicine | Zerbaxa |
| INN | ceftolozane / tazobactam |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information | Zerbaxa: Pending EC decision |
Re-examination of public-health recommendation
| Name of referral | Synchron |
| More information | Synchron Research Service: suspension of medicines over flawed studies |