EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its September 2020 meeting.
The CHMP adopted a positive opinion for Exparel (bupivacaine), for the treatment of post-operative pain.
The Committee recommended granting marketing authorisations for two vaccines: MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), for prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y; and Supemtek (Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture)), for prophylaxis against influenza.
The CHMP recommended granting a marketing authorisation under exceptional circumstances for Obiltoxaximab SFL* (obiltoxaximab), for the treatment or post-exposure prophylaxis of inhalational anthrax.
The biosimilar medicine Nyvepria (pegfilgrastim) received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy.
The Committee recommended granting a marketing authorisation for the generic medicine Rivaroxaban Accord (rivaroxaban), an anticoagulant intended for the treatment and prevention of venous thromboembolism, pulmonary embolism and the prevention of atherothrombotic events in adults with various risk factors for such events.
The CHMP recommended granting a marketing authorisation for Phelinun (melphalan), a hybrid medicine for the treatment of certain haematological and other cancers and as reduced intensity conditioning treatment prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in adults and children. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorised reference product and in part on new data.
Start of re-examination of recommendations for new medicines
The applicants for Elzonris (tagraxofusp) and Gamifant (emapalumab) have requested re-examination of the Committee's negative opinions for these medicines adopted at the July 2020 meeting. The CHMP will now re-examine the opinions and issue final recommendations.
For more information on these negative opinions, see the question-and-answer documents in the grid below.
Fifteen recommendations on extensions of therapeutic indication
The Committee recommended granting an extension of indication to Olumiant (baricitinib) to include the treatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. This is the first medicine for moderate as well as severe atopic dermatitis that patients can take orally. For more information, see the press release in the grid below.
The CHMP recommended granting an extension of indication to Orfadin (nitisinone) to include the treatment of alkaptonuria, a rare metabolic disorder, in adult patients. There are currently no approved medicines for alkaptonuria and treatment options are limited to dealing with the outcomes of the disease as they arise. For more information, see the press release in the grid below.
The Committee recommended granting an extension of indication for Velphoro (mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches) to include control of serum phosphorus levels in children aged two or older with chronic kidney disease (CDK) stages 4-5 or with CDK on dialysis. For more information, see the press release in the grid below.
Other extensions of indication recommended by the Committee were for Deltyba, Flucelvax Tetra, Fycompa, Lynparza, Opdivo, Symkevi, Tecentriq, Yervoy, Zavicefta, Zejula and two extensions of indication for Kalydeco.
Outcome of review of dexamethasone for the treatment of COVID-19
The CHMP completed its review of results from the RECOVERY study arm that involved the use of the corticosteroid medicine dexamethasone in the treatment of patients with COVID-19 admitted to hospital, and has concluded that dexamethasone can be considered a treatment option for patients who require oxygen therapy (from supplemental oxygen to mechanical ventilation).
For more information, please see the public health recommendation in the grid below.
Outcome of re-examination of recommendation on ranitidine medicines
The CHMP confirmed its recommendation to suspend all ranitidine medicines in the EU due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA). This follows a re-examination of CHMP’s April 2020 opinion, which was requested by one of the companies marketing ranitidine medicines. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on animal studies.
For more information, please see the public health recommendation in the grid below.
Withdrawal of application
The application for an initial marketing authorisation for Upkanz (deferiprone) was withdrawn. This medicine was intended for the treatment of pantothenate kinase-associated neurodegeneration, a rare inherited disease that causes increasing damage in the brain.
A question-and-answer document on this withdrawal is available in the grid below.
Agenda and minutes
The agenda of the September 2020 meeting is published on EMA's website. Minutes of the July 2020 CHMP meeting will be published in the coming weeks.
CHMP statistics
Key figures from the September 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 | Exparel |
| INN | bupivacaine |
| Marketing-authorisation applicant | Pacira Ireland Limited |
| Therapeutic indication | Treatment of post-operative pain |
| More information | Exparel: Pending EC decision |
| Name of medicine | MenQuadfi |
| Common name | meningococcal group A, C, W and Y conjugate vaccine |
| Marketing-authorisation applicant | Sanofi Pasteur |
| Therapeutic indication | Prophylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y |
| More information | MenQuadfi: Pending EC decision |
| Name of medicine | Obiltoxaximab SFL |
| INN | obiltoxaximab |
| Marketing-authorisation applicant | SFL Regulatory Services GmbH |
| Therapeutic indication | Treatment or post-exposure prophylaxis of inhalational anthrax. |
| More information |
| Name of medicine | Supemtek |
| Common name | Quadrivalent Influenza Vaccine (recombinant, prepared in cell culture) |
| Marketing-authorisation applicant | Sanofi Pasteur |
| Therapeutic indication | Prophylaxis against influenza |
| More information |
| Name of medicine | Nyvepria |
| INN | pegfilgrastim |
| Marketing-authorisation applicant | Pfizer Europe MA EEIG |
| Therapeutic indication | Reduction in the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy |
| More information | Nyvepria: Pending EC decision |
| Name of medicine | Rivaroxaban Accord |
| INN | rivaroxaban |
| Marketing-authorisation applicant | Accord Healthcare S.L.U. |
| Therapeutic indication | Treatment and prevention of venous thromboembolism, pulmonary embolism, and the prevention of atherothrombotic events in adults with various risk factors for such events |
| More information |
| Name of medicine | Phelinun |
| INN | melphalan |
| Marketing-authorisation applicant | ADIENNE S.r.l. S.U. |
| Therapeutic indication | Treatment of certain haematological and other cancers and as reduced intensity conditioning treatment prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in adults and children |
| More information |
| Name of medicine | Elzonris |
| INN | tagraxofusp |
| Marketing-authorisation applicant | Stemline Therapeutics B.V. |
| Therapeutic indication |
Treatment of blastic plasmacytoid dendritic cell neoplasm |
| More information |
| 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 | Deltyba |
| INN | delamanid |
| Marketing-authorisation holder | Otsuka Novel Products GmbH |
| More information | Deltyba: Pending EC decision |
| Name of medicine | Fycompa |
| INN | perampanel |
| Marketing-authorisation holder | Eisai GmbH |
| More information | Fycompa: Pending EC decision |
| Name of medicine | Flucelvax Tetra |
| Common name | influenza vaccine (surface antigen, inactivated, prepared in cell cultures) |
| Marketing-authorisation holder | Seqirus Netherlands B.V. |
| More information | Flucelvax Tetra: Pending EC decision |
| Name of medicine | Kalydeco |
| INN | ivacaftor |
| Marketing-authorisation holder | Vertex Pharmaceuticals (Ireland) Limited |
| More information |
| Name of medicine | Lynparza |
| INN | olaparib |
| Marketing-authorisation holder | AstraZeneca AB |
| More information | Lynparza: Pending EC decision |
| Name of medicine | Olumiant |
| INN | baricitinib |
| Marketing-authorisation holder | Eli Lilly Nederland B.V. |
| More information |
News: New oral treatment for moderate to severe atopic dermatitis |
| Name of medicine | Opdivo |
| INN | nivolumab |
| Marketing-authorisation holder | Bristol-Myers Squibb Pharma EEIG |
| More information | Opdivo: Pending EC decision |
| Name of medicine | Orfadin |
| INN | nitisinone |
| Marketing-authorisation holder | Swedish Orphan Biovitrum International AB |
| More information | Orfadin: Pending EC decision
News: First treatment for rare metabolic disorder alkaptonuria |
| Name of medicine | Symkevi |
| INN | tezacaftor / ivacaftor |
| Marketing-authorisation holder | Vertex Pharmaceuticals (Ireland) Limited |
| More information | Symkevi : Pending EC decision |
| Name of medicine | Tecentriq |
| INN | atezolizumab |
| Marketing-authorisation applicant | Roche Registration GmbH |
| More information | Tecentriq: Pending EC decision |
| Name of medicine | Velphoro |
| INN | mixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches |
| Marketing-authorisation applicant | Vifor Fresenius Medical Care Renal Pharma France |
| More information | Velphoro: Pending EC decision
News: New treatment for children with chronic kidney disease |
| Name of medicine | Yervoy |
| INN | ipilimumab |
| Marketing-authorisation applicant | Bristol-Myers Squibb Pharma EEIG |
| More information | Yervoy: Pending EC decision |
| Name of medicine | Zejula |
| INN | niraparib |
| Marketing-authorisation applicant | GlaxoSmithKline (Ireland) Limited |
| More information | Zejula: Pending EC decision |
| Name of medicine | Zavicefta |
| INN | ceftazidime / avibactam |
| Marketing-authorisation applicant | Pfizer Ireland Pharmaceuticals |
| More information | Zavicefta: Pending EC decision |
| Name of medicine | Ranitidine-containing medicinal products |
| INN | ranitidine |
| More information | Ranitidine Article-31 referral: EMA confirms recommendation to suspend all ranitidine medicines in the EU |
| Name of medicine | Dexamethasone |
| More information | EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation |
| Name of medicine | Upkanz |
| INN | deferiprone |
| Marketing-authorisation applicant | Apotex B.V. |
| More information | Upkanz: Withdrawn application |