Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2020

News 18/09/2020

Seven new medicines recommended for approval

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.

CHMP statistics: September 2020

Positive recommendations on new medicines

Name of medicineExparel 
INNbupivacaine 
Marketing-authorisation applicantPacira Ireland Limited
Therapeutic indicationTreatment of post-operative pain
More informationExparel: Pending EC decision

 

Name of medicineMenQuadfi 
Common namemeningococcal group A, C, W and Y conjugate vaccine 
Marketing-authorisation applicantSanofi Pasteur
Therapeutic indicationProphylaxis against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y
More informationMenQuadfi: Pending EC decision

 

Name of medicineObiltoxaximab SFL 
INNobiltoxaximab
Marketing-authorisation applicantSFL Regulatory Services GmbH
Therapeutic indicationTreatment or post-exposure prophylaxis of inhalational anthrax.
More information

Obiltoxaximab SFL: Pending EC decision

 

Name of medicineSupemtek 
Common nameQuadrivalent Influenza Vaccine (recombinant, prepared in cell culture)
Marketing-authorisation applicantSanofi Pasteur
Therapeutic indicationProphylaxis against influenza
More information

Supemtek: Pending EC decision

 

Positive recommendation on new biosimilar medicine

Name of medicineNyvepria
INNpegfilgrastim 
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indicationReduction in the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy
More informationNyvepria: Pending EC decision

 

Positive recommendation on new generic medicine

Name of medicineRivaroxaban Accord 
INNrivaroxaban
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment and prevention of venous thromboembolism, pulmonary embolism, and the prevention of atherothrombotic events in adults with various risk factors for such events
More information

Rivaroxaban Accord: Pending EC decision

 

Positive recommendation on new hybrid medicine

Name of medicinePhelinun
INNmelphalan
Marketing-authorisation applicantADIENNE S.r.l. S.U.
Therapeutic indicationTreatment 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

Phelinun: Pending EC decision

 

Start of re-examination of recommendation for new medicine

Name of medicineElzonris
INNtagraxofusp
Marketing-authorisation applicantStemline Therapeutics B.V.
Therapeutic indication

Treatment of blastic plasmacytoid dendritic cell neoplasm

More information

Elzonris: Questions and answers

 

Name of medicineGamifant
INNemapalumab
Marketing-authorisation applicantSwedish Orphan Biovitrum AB (publ)
Therapeutic indicationTreatment of primary haemophagocytic lymphohistiocytosis in children under 18 years of age
More informationGamifant: Questions and answers

 

Positive recommendations on extensions of indications

Name of medicineDeltyba
INNdelamanid
Marketing-authorisation holderOtsuka Novel Products GmbH
More informationDeltyba: Pending EC decision

 

Name of medicineFycompa
INNperampanel
Marketing-authorisation holderEisai GmbH
More informationFycompa: Pending EC decision

 

Name of medicineFlucelvax Tetra 
Common nameinfluenza vaccine (surface antigen, inactivated, prepared in cell cultures)
Marketing-authorisation holderSeqirus Netherlands B.V.
More informationFlucelvax Tetra: Pending EC decision

 

Name of medicineKalydeco
INNivacaftor
Marketing-authorisation holderVertex Pharmaceuticals (Ireland) Limited
More information

Kalydeco (X-83-G): Pending EC decision


Kalydeco (II-86): Pending EC decision

 

Name of medicineLynparza
INN olaparib 
Marketing-authorisation holderAstraZeneca AB
More informationLynparza: Pending EC decision

 

Name of medicineOlumiant 
INNbaricitinib
Marketing-authorisation holderEli Lilly Nederland B.V.
More information

Olumiant: Pending EC decision

News: New oral treatment for moderate to severe atopic dermatitis

 

Name of medicineOpdivo
INNnivolumab
Marketing-authorisation holderBristol-Myers Squibb Pharma EEIG
More informationOpdivo: Pending EC decision

 

Name of medicineOrfadin
INNnitisinone
Marketing-authorisation holderSwedish Orphan Biovitrum International AB
More informationOrfadin: Pending EC decision

News: First treatment for rare metabolic disorder alkaptonuria 

 

Name of medicineSymkevi 
INNtezacaftor / ivacaftor 
Marketing-authorisation holderVertex Pharmaceuticals (Ireland) Limited
More informationSymkevi : Pending EC decision

 

Name of medicineTecentriq
INNatezolizumab 
Marketing-authorisation applicantRoche Registration GmbH
More informationTecentriq: Pending EC decision

 

Name of medicineVelphoro
INNmixture of polynuclear iron(III)-oxyhydroxide, sucrose and starches
Marketing-authorisation applicantVifor Fresenius Medical Care Renal Pharma France
More informationVelphoro: Pending EC decision

News: New treatment for children with chronic kidney disease

 

Name of medicineYervoy
INNipilimumab
Marketing-authorisation applicantBristol-Myers Squibb Pharma EEIG
More informationYervoy: Pending EC decision

 

Name of medicineZejula 
INNniraparib
Marketing-authorisation applicantGlaxoSmithKline (Ireland) Limited
More informationZejula: Pending EC decision

 

Name of medicineZavicefta 
INNceftazidime / avibactam
Marketing-authorisation applicantPfizer Ireland Pharmaceuticals
More informationZavicefta: Pending EC decision

 

Outcome of re-examination of public-health recommendation

Name of medicineRanitidine-containing medicinal products
INNranitidine
More informationRanitidine Article-31 referral: EMA confirms recommendation to suspend all ranitidine medicines in the EU

 

Opinions on any scientific matter (Article 5(3))

Withdrawal of initial marketing authorisation application

Name of medicineUpkanz
INNdeferiprone
Marketing-authorisation applicantApotex B.V.
More informationUpkanz: Withdrawn application

 

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