EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the European Union.
The CHMP adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis is not used, cannot be used or is not available. Placed in the vagina, the ring slowly releases the antiretroviral medicine dapivirine over a period of 28 days.
This is the eleventh medicine recommended by EMA under EU Medicines for all (EU-M4All), a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the EU under Article 58 of Regulation (EC) No 726/2004. For more information, see the press release in the grid below.
The Committee recommended granting a conditional marketing authorisation for Blenrep* (belantamab mafodotin), a new antibody-drug conjugate for adult patients with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody. Blenrep benefited from the support of the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. For more information, see the press release in the grid below.
The CHMP recommended granting a marketing authorisation for Adakveo* (crizanlizumab), for the prevention of recurrent vaso-occlusive crises (when blood vessels are blocked by abnormal red blood cells, restricting the flow of blood to an organ) in patients with sickle cell disease.
The CHMP adopted a positive opinion for Arikayce liposomal* (amikacin), for the treatment of non-tuberculous mycobacterial lung infections caused by Mycobacterium avium Complex in adults with limited treatment options who do not have cystic fibrosis.
The Committee recommended granting a conditional marketing authorisation for Ayvakyt* (avapritinib), for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours harbouring the platelet-derived growth factor receptor alpha D842V mutation.
The Committee adopted a positive opinion for Calquence* (acalabrutinib) for the treatment of chronic lymphocytic leukaemia, a type of cancer affecting white blood cell called lymphocytes.
Jyseleca (filgotinib) received a positive opinion for the treatment of rheumatoid arthritis.
The CHMP recommended granting a marketing authorisation for Zynrelef (bupivacaine / meloxicam) for the treatment of post-operative pain.
The biosimilar medicine Equidacent (bevacizumab) received a positive opinion 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 CHMP recommended granting marketing authorisations for two generic medicines: Arsenic trioxide medac (arsenic trioxide), for the treatment of acute promyelocytic leukaemia (blood cancer) and Fampridine Accord (fampridine), intended to improve walking of adult patients suffering from multiple sclerosis with walking disability.
Negative recommendations on new medicines
The CHMP adopted negative opinions recommending the refusal of marketing authorisations for Elzonris (tagraxofusp) and Gamifant (emapalumab).
Elzonris was expected to be used for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive type of acute myeloid leukaemia (blood cancer). Gamifant was expected to be used to treat primary haemophagocytic lymphohistiocytosis (a genetic disease characterised by an overactive immune system) in children under 18 years of age.
For more information on these negative opinions, see the question-and-answer documents in the grid below.
Nine recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Crysvita, HyQvia, Imbruvica, Imfinzi, Kalydeco, Latuda, NovoThirteen, Prezista and Shingrix.
Change to non-prescription status
The CHMP recommended a change in classification status from prescription to non-prescription for Fortacin (lidocaine / prilocaine), a medicine to treat men with primary (lifelong) premature ejaculation. For more information, see the summary of opinion document in the grid below.
Outcome of review on medicines tested by Panexcell Clinical Laboratories
The Committee recommended the suspension of the marketing authorisations of generic medicines tested by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India. The recommendation comes after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies, which are used to show that a generic medicine produces the same amount of active substance in the body as the reference medicine.
For more information, see the public health recommendation in the grid below.
Outcome of review on Yondelis
The CHMP recommended that the use of Yondelis (trabectedin) in treating ovarian cancer remains unchanged following a review of a study that investigated Yondelis as a third line treatment in patients with ovarian cancer. However, the study results will be included in the medicine’s product information to provide healthcare professionals with the most up-to-date information.
For more information, see the public health recommendation in the grid below.
Start of referral
The Committee started a review of the results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. The review aims to provide an opinion on the results of the study and in particular the potential use of dexamethasone for the treatment of adults with COVID-19. For more information, see the start-of-referral document in the grid below.
Withdrawals of applications
Applications for initial marketing authorisations for Rayoqta (abicipar pegol) and Abilify MyCite (aripiprazole) have been withdrawn.
Rayoqta was expected to be used to treat age-related macular degeneration, a disease which affects the central part of the retina (called the macula) at the back of the eye and causes gradual loss of vision. Abilify MyCite was expected to be used to treat schizophrenia and bipolar I disorder.
Question-and-answer documents on these withdrawals are available in the grid below.
Agenda and minutes
The agenda of the July meeting is published on EMA's website. Minutes of the June 2020 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the July 2020 CHMP meeting are represented in the graphic below.
* These products were designated as an orphan medicines during their 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 medicines' orphan status and granting the medicines ten years of market exclusivity.
| Name of medicine | Adakveo |
| INN | crizanlizumab |
| Marketing-authorisation applicant | Novartis Europharm Limited |
| Therapeutic indication | Prevention of recurrent vaso-occlusive crises in patients with sickle cell disease |
| More information | Adakveo: Pending EC decision |
| Name of medicine | Arikayce liposomal |
| INN | amikacin |
| Marketing-authorisation applicant | Insmed Netherlands B.V. |
| Therapeutic indication | Treatment of non-tuberculous mycobacterial lung infections caused by Mycobacterium avium Complex in adults with limited treatment options who do not have cystic fibrosis |
| More information | Arikayce liposomal: Pending EC decision |
| Name of medicine | Ayvakyt |
| INN | avapritinib |
| Marketing-authorisation applicant | Blueprint Medicines (Netherlands) B.V. |
| Therapeutic indication | Treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours harbouring the platelet-derived growth factor receptor alpha D842V mutation |
| More information |
| Name of medicine | Blenrep |
| INN | belantamab mafodotin |
| Marketing-authorisation applicant | GlaxoSmithKline (Ireland) Limited |
| Therapeutic indication | Treatment of relapsed and refractory multiple myeloma |
| More information |
News: First antibody-drug conjugate for multiple myeloma patients with limited treatment options |
| Name of medicine | Calquence |
| INN | acalabrutinib |
| Marketing-authorisation applicant | AstraZeneca AB |
| Therapeutic indication | Treatment of chronic lymphocytic leukaemia |
| More information | Calquence: Pending EC decision |
| Name of medicine | Jyseleca |
| INN | filgotinib |
| Marketing-authorisation applicant | Gilead Sciences Ireland UC |
| Therapeutic indication | Treatment of rheumatoid arthritis |
| More information |
| Name of medicine | Zynrelef |
| INN | bupivacaine / meloxicam |
| Marketing-authorisation applicant | Heron Therapeutics, B.V. |
| Therapeutic indication | Treatment of post-operative pain |
| More information |
| Name of medicine | Equidacent |
| INN | bevacizumab |
| Marketing-authorisation applicant | Centus Biotherapeutics Europe Limited |
| 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 | Equidacent: Pending EC decision |
| Name of medicine | Arsenic trioxide medac |
| INN | arsenic trioxide |
| Marketing-authorisation applicant | medac Gesellschaft fur klinische Spezialpraparate mbH |
| Therapeutic indication | Treatment of acute promyelocytic leukaemia |
| More information | Arsenic trioxide medac: Pending EC decision |
| Name of medicine | Fampridine Accord |
| INN | fampridine |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Improvement of walking in adult patients with multiple sclerosis with walking disability |
| More information | Fampridine Accord: Pending EC decision |
| Name of medicine | Dapivirine Vaginal Ring 25 mg |
| INN | dapivirine |
| Marketing-authorisation applicant | International Partnership for Microbicides Belgium AISBL |
| Therapeutic indication | Prophylaxis against HIV-1 infection via vaginal intercourse in HIV-uninfected women 18 years and older in combination with safer sex practices when oral pre-exposure prophylaxis is not/cannot be used or is not available |
| More information |
Dapivirine Vaginal Ring 25 mg: Opinion on medicine for use outside EU |
| Name of medicine | Elzonris |
| INN | tagraxofusp |
| Marketing-authorisation applicant | Stemline Therapeutics B.V. |
| Therapeutic indication | Treatment of blastic plasmacytoid dendritic cell neoplasm |
| More information | Elzonris: Questions and answers |
| Name of medicine | Gamifant |
| INN | emapalumab |
| Marketing-authorisation applicant | Swedish Orphan Biovitrum AB (publ) |
| Therapeutic indication | Treatment of primary haemophagocytic lymphohistiocytosis in children under 18 years of age |
| More information | Gamifant: Questions and answers |
| Name of medicine | Crysvita |
| INN | burosumab |
| Marketing-authorisation holder | Kyowa Kirin Holdings B.V. |
| More information | Crysvita: Pending EC decision |
| Name of medicine | HyQvia |
| INN | human normal immunoglobulin |
| Marketing-authorisation holder | Baxalta Innovations GmbH |
| More information | HyQvia: 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 | Imfinzi |
| INN | durvalumab |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Imfinzi: Pending EC decision |
| Name of medicine | Kalydeco |
| INN | ivacaftor |
| Marketing-authorisation holder | Vertex Pharmaceuticals (Ireland) Limited |
| More information | Kalydeco: Pending EC decision |
| Name of medicine | Latuda |
| INN | lurasidone |
| Marketing-authorisation holder | Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. |
| More information | Latuda: Pending EC decision |
| Name of medicine | NovoThirteen |
| INN | catridecacog |
| Marketing-authorisation holder | Novo Nordisk A/S |
| More information | NovoThirteen: Pending EC decision |
| Name of medicine | Prezista |
| INN | darunavir |
| Marketing-authorisation holder | Janssen-Cilag International NV |
| More information | Prezista: Pending EC decision |
| Name of medicine | Shingrix |
| Common name | herpes zoster vaccine (recombinant, adjuvanted) |
| Marketing-authorisation holder | GlaxoSmithkline Biologicals SA |
| More information | Shingrix: Pending EC decision |
| Name of medicine | Reyataz |
| INN | atazanavir sulphate |
| Marketing-authorisation applicant | Bristol-Myers Squibb Pharma EEIG |
| More information | Reyataz: Pending EC decision |
| Name of medicine | Fortacin |
| INN | lidocaine / prilocaine |
| Marketing-authorisation applicant | Recordati Ireland Ltd |
| More information | Fortacin: Pending EC decision |
| Name of medicine | Votubia |
| INN | everolimus |
| Marketing-authorisation applicant | Novartis Europharm Limited |
| More information | Questions and answers on the use of Votubia in children from 6 months of age |
| Name of medicine | Panexcell |
| More information | Panexcell Article-31 referral: Panexcell Clinical Laboratories: suspension of medicines over flawed studies |
| Name of medicine | Yondelis |
| INN | Pharma Mar S.A. |
| More information | Yondelis Article-20 procedure: Authorised uses of cancer medicine Yondelis unchanged following review of new data |
| Name of medicine | Ibuprofen Kabi 400 mg Infusionslösung and associated names |
| Marketing-authorisation holder | Fresenius Kabi Deutschland GmbH |
| More information | Ibuprofen Kabi 400 mg Infusionslösung and associated names Article 29(4) referral: EMA recommends authorisation of Ibuprofen Kabi (ibuprofen, 400 mg solution for infusion) in the EU |
| Name of medicine | Dexamethasone |
| More information | EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support |
| Name of medicine | Rayoqta |
| INN | abicipar pegol |
| Marketing-authorisation applicant | Allergan Pharmaceuticals International Limited |
| More information | Rayoqta: Withdrawn application |
| Name of medicine | Abilify MyCite |
| INN | aripiprazole |
| Marketing-authorisation applicant | Otsuka Pharmaceutical Netherlands B.V. |
| More information | Abilify Mycite: Withdrawn application |