EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its May 2020 meeting.
The Committee recommended granting a marketing authorisation for a new vaccine that provides active immunisation to prevent Ebola virus disease in individuals aged one year and older. The new Ebola vaccine consists of two components, Zabdeno (Ad26.ZEBOV) and Mvabea (MVA-BN-Filo). Zabdeno is given first and Mvabea is administered approximately eight weeks later as a booster. Zabdeno and Mvabea were evaluated under EMA's accelerated assessment mechanism, a tool which aims to speed up patients' access to new medicines if there is an unmet medical need. For more information, see the press release in the grid below.
The CHMP recommended granting a marketing authorisation for Hepcludex* (bulevirtide), for the treatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease. Because there are no treatments currently approved for hepatitis D, Hepcludex 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.
Piqray (alpelisib) received a positive opinion from the CHMP for the treatment of locally advanced or metastatic breast cancer with a PIK3CA mutation.
The CHMP recommended granting a conditional marketing authorisation for Rozlytrek (entrectinib), for the treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase gene fusion, or patients with ROS1-positive advanced non-small cell lung cancer.
Xenleta (lefamulin) received a positive opinion for the treatment of community-acquired pneumonia in adults.
The biosimilar medicine Zercepac (trastuzumab) received a positive opinion for the treatment of breast and gastric cancer.
The generic medicine Apixaban Accord (apixaban) received a positive opinion for the treatment and prevention of venous thromboembolic events in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation.
The Committee recommended extensions of indication for Invokana, Lynparza, Ofev, Sivextro and Taltz.
The CHMP discussed the status of the review of remdesivir for treating patients with COVID-19. On 30 April 2020, the CHMP started a rolling review of data and the first cycle of this rolling review was concluded on 15 May; the CHMP requested some further data and agreed that the next step would be for the company to submit this data together with an application for a conditional marketing authorisation. The company has not yet submitted an application but it is expected to do so shortly. Once an application has been submitted, the Committee will assess it under a timeline which will be reduced to the absolute minimum to still allow for a thorough evaluation of benefits and risks, meaning an opinion could come soon depending on the robustness of the data submitted.
Applications for initial marketing authorisations for Erlotinib Accord (erlotinib) and Fingolimod Mylan (fingolimod) have been withdrawn. Erlotinib Accord was intended for the treatment of non-small-cell lung cancer and pancreatic cancer. Fingolimod Mylan was intended for the treatment of multiple sclerosis.
Question-and-answer documents on these withdrawals are available in the grid below.
The agenda of the May meeting is published on EMA's website. Minutes of the April 2020 CHMP meeting will be published in the coming weeks.
Key figures from the May 2020 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.
| Name of medicine | Hepcludex |
| INN | bulevirtide |
| Marketing-authorisation applicant | MYR GmbH |
| Therapeutic indication | Treatment of chronic hepatitis delta virus infection in adult patients with compensated liver disease |
| More information | Hepcludex: Pending EC decision |
| Name of medicine | Mvabea |
| Common name | Ebola vaccine (MVA-BN-Filo [recombinant]) |
| Marketing-authorisation applicant | Janssen-Cilag International N.V. |
| Therapeutic indication | Prophylaxis against Zaire ebolavirus disease |
| More information |
Press release:New vaccine for prevention of Ebola virus disease recommended for approval in the European Union |
| Name of medicine | Piqray |
| INN | alpelisib |
| Marketing-authorisation applicant | Novartis Europharm Limited |
| Therapeutic indication | Treatment of locally advanced or metastatic breast cancer with a PIK3CA mutation |
| More information | Piqray: Pending EC decision |
| Name of medicine | Rozlytrek |
| INN | entrectinib |
| Marketing-authorisation applicant | Roche Registration GmbH |
| Therapeutic indication | Treatment of patients whose solid tumours have a neurotrophic tyrosine receptor kinase gene fusion, or patients with ROS1-positive advanced non-small cell lung cancer |
| More information | Rozlytrek: Pending EC decision |
| Name of medicine | Xenleta |
| INN | lefamulin |
| Marketing-authorisation applicant | Nabriva Therapeutics Ireland DAC |
| Therapeutic indication | Treatment of community-acquired pneumonia in adults |
| More information | Xenleta: Pending EC decision |
| Name of medicine | Zabdeno |
| Common name | Ebola vaccine (Ad26.ZEBOV-GP [recombinant]) |
| Marketing-authorisation applicant | Janssen-Cilag International N.V. |
| Therapeutic indication | Prophylaxis against Zaire ebolavirus disease |
| More information |
Press release:New vaccine for prevention of Ebola virus disease recommended for approval in the European Union |
| Name of medicine | Zercepac |
| INN | trastuzumab |
| Marketing-authorisation holder | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment of breast and gastric cancer |
| More information | Zercepac: Pending EC decision |
| Name of medicine | Apixaban Accord |
| INN | apixaban |
| Marketing-authorisation holder | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment and prevention of venous thromboembolic events in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation |
| More information | Apixaban Accord: Pending EC decision |
| Name of medicine | Invokana |
| INN | canagliflozin |
| Marketing-authorisation holder | Janssen-Cilag International NV |
| More information | Invokana: Pending EC decision |
| Name of medicine | Lynparza |
| INN | olaparib |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Lynparza: Pending EC decision |
| Name of medicine | Ofev |
| INN | nintedanib |
| Marketing-authorisation holder | Boehringer Ingelheim International GmbH |
| More information | Ofev: Pending EC decision |
| Name of medicine | Sivextro |
| INN | tedizolid phosphate |
| Marketing-authorisation holder | Merck Sharp & Dohme B.V. |
| More information | Sivextro: Pending EC decision |
| Name of medicine | Taltz |
| INN | ixekizumab |
| Marketing-authorisation holder | Eli Lilly Nederland B.V. |
| More information | Taltz: Pending EC decision |
| Name of medicine | Erlotinib Accord |
| INN | erlotinib |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| More information | Erlotinib Accord: Withdrawn application |
| Name of medicine | Fingolimod Mylan |
| INN | fingolimod |
| Marketing-authorisation applicant | Mylan Ireland Limited |
| More information | Fingolimod Mylan: Withdrawn application |
| Name of medicine | Trumenba |
| Common name | meningococcal group B vaccine (recombinant, adsorbed) |
| Marketing-authorisation holder | Pfizer Europe MA EEIG |
| More information | Questions and answers on the use of Trumenba in children between 1 and 9 years of age |
| Name of medicine | Vokanamet |
| Common name | canagliflozin / metformin |
| Marketing-authorisation holder | Janssen-Cilag International N.V. |
| More information | Questions and answers on the use of Vokanamet in diabetic kidney disease |