Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2020

News 31/01/2020

Fifteen new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended fifteen medicines for approval at its January 2020 meeting.

The Committee recommended granting a marketing authorisation for Givlaari* (givosiran), the first treatment for acute hepatic porphyria in adults and adolescents aged 12 years and older. Acute hepatic porphyria is a rare life-threatening genetic condition that causes attacks of severe abdominal pain, vomiting and nervous system disorders, such as seizures, depression and anxiety.

Givlaari benefited from support of the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. This interaction led to a more robust application package to demonstrate the medicine’s benefits and risks, which allowed its accelerated assessment. For more information, see the press release in the grid below.

The CHMP adopted a positive opinion for Rybelsus (semaglutide) for the treatment of adults with insufficiently controlled type 2 diabetes to improve glycaemic control as an adjunct to diet and exercise. It is the first glucagon-like peptide (GLP-1) receptor agonist treatment - a class of non-insulin medicines for people with type 2 diabetes - developed for oral use, providing patients with another option to treat the disease without injections. For more information, see the press release in the grid below.

The Committee recommended granting a marketing authorisation for Vaxchora (Cholera vaccine (recombinant, live, oral)) for prophylaxis against cholera, a very serious disease caused by Vibrio cholerae, in adults and children.

Liumjev (insulin lispro) received a positive opinion from the CHMP for the treatment of diabetes mellitus in adults.

The CHMP recommended granting marketing authorisations for Nilemdo (bempedoic acid) and Nustendi (bempedoic acid / ezetimibe) for the treatment of primary hypercholesterolaemia (high blood cholesterol that has no identifiable cause) and mixed dyslipidaemia (abnormally levels of fat in the blood).

Nubeqa (darolutamide) received a positive opinion for the treatment of prostate cancer.

The CHMP adopted a positive opinion for Staquis (crisaborole) for the treatment of atopic dermatitis.

The biosimilar medicine Ruxience (rituximab) received a positive opinion for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and Pemphigus vulgaris.

The CHMP recommended granting marketing authorisations for four generic medicines: Azacitidine betapharm (azacytidine) and Azacitidine Mylan (azacitidine), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia; Arsenic trioxide Mylan (arsenic trioxide), for the treatment of acute promyelocytic leukaemia; and Cinacalcet Accordpharma (cinacalcet), for the treatment of secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism.

The CHMP recommended granting marketing authorisations for two hybrid medicines: Budesonide/Formoterol Teva Pharma B.V. (budesonide / formoterol fumarate dihydrate), for the treatment of asthma and chronic obstructive pulmonary disease; and Trepulmix* (treprostinil sodium), for the treatment of chronic thromboembolic pulmonary hypertension. 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.

Six recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Ameluz, MabThera, Rezolsta, Suliqua, Tybost and Venclyxto.

Withdrawals of applications

The application for an initial marketing authorisation for Idhifa (enasidenib) was withdrawn. This medicine was intended for the treatment of acute myeloid leukaemia, a cancer of white blood cells.

The application to extend the use of Keytruda (pembrolizumab) in the treatment of cancer of the oesophagus was also withdrawn.

Question-and-answer documents on these withdrawals are available in the grid below.

Agenda and minutes

The agenda of the January meeting is published on EMA's website. Minutes of the December 2019 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the January 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: January 2020

Positive recommendations on new medicines

Name of medicineGivlaari
International non-proprietary name (INN)givosiran
Marketing-authorisation applicantAlnylam Netherlands B.V.
Therapeutic indicationTreatment of acute hepatic porphyria
More informationGivlaari: Pending EC decision
Press release First treatment for acute hepatic porphyria

 

Name of medicineLiumjev
INNinsulin lispro
Marketing-authorisation applicantEli Lilly Nederland B.V.
Therapeutic indicationTreatment of diabetes mellitus in adults
More informationLiumjev: Pending EC decision

 

Name of medicineNilemdo
INNbempedoic acid 
Marketing-authorisation applicantFGK Representative Service GmbH
Therapeutic indicationTreatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia
More informationNilemdo: Pending EC decision

 

Name of medicineNubeqa
INNdarolutamide
Marketing-authorisation applicantBayer AG
Therapeutic indicationTreatment of prostate cancer
More informationNubeqa: Pending EC decision

 

Name of medicineNustendi
INNbempedoic acid / ezetimibe
Marketing-authorisation applicantFGK Representative Service GmbH
Therapeutic indicationTreatment of primary hypercholesterolaemia and mixed dyslipidaemia
More informationNustendi: Pending EC decision

 

Name of medicineRybelsus
INNsemaglutide
Marketing-authorisation applicantNovo Nordisk A/S
Therapeutic indicationTreatment of type 2 diabetes
More informationRybelsus: Pending EC decision
Press release First oral GLP-1 treatment for type 2 diabetes

 

Name of medicineStaquis
INNcrisaborole
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indicationTreatment of atopic dermatitis
More informationStaquis: Pending EC decision

 

Name of medicineVaxchora
Common nameCholera vaccine (recombinant, live, oral)
Marketing-authorisation applicantEmergent Netherlands B.V.
Therapeutic indicationProphylaxis against disease caused by Vibrio cholerae in adults and children
More informationVaxchora: Pending EC decision

 

Positive recommendation on new biosimilar medicine

Name of medicineRuxience
INNrituximab 
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indicationTreatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and Pemphigus vulgaris
More informationRuxience: Pending EC decision

 

Positive recommendations on new generic medicines

Name of medicineArsenic trioxide Mylan
INNarsenic trioxide
Marketing-authorisation applicantMylan Ireland Limited
Therapeutic indicationTreatment of acute promyelocytic leukaemia
More informationArsenic trioxide Mylan: Pending EC decision

 

Name of medicineAzacitidine betapharm
INNazacitidine
Marketing-authorisation applicantbetapharm Arzneimittel GmbH
Therapeutic indicationTreatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia
More informationAzacitidine betapharm: Pending EC decision

 

Name of medicineAzacitidine Mylan
INNazacitidine
Marketing-authorisation applicantMylan Ireland Limited
Therapeutic indicationTreatment of myelodysplastic syndromes, chronic myelomonocytic leukaemia and acute myeloid leukaemia
More informationAzacitidine Mylan: Pending EC decision

 

Name of medicineCinacalcet Accordpharma
INNcinacalcet
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of secondary hyperparathyroidism, parathyroid carcinoma and primary hyperparathyroidism
More informationCinacalcet Accordpharma: Pending EC decision

 

Positive recommendations on new hybrid medicines

Name of medicineBudesonide/Formoterol Teva Pharma B.V.
INNbudesonide / formoterol fumarate dihydrate
Marketing-authorisation applicantTeva Pharma B.V.
Therapeutic indicationTreatment of asthma and chronic obstructive pulmonary disease
More informationBudesonide / Formoterol Teva Pharma B.V.: Pending EC decision

 

Name of medicineTrepulmix
INNtreprostinil sodium
Marketing-authorisation applicantSciPharm Sarl
Therapeutic indicationTreatment of chronic thromboembolic pulmonary hypertension
More informationTrepulmix: Pending EC decision

 

Positive recommendations on extensions of indications

Name of medicineAmeluz
INN5-aminolevulinic acid
Marketing-authorisation holderBiofrontera Bioscience GmbH
More informationAmeluz: Pending EC decision

 

Name of medicineMabThera
INNrituximab
Marketing-authorisation holderRoche Registration GmbH
More informationMabThera: Pending EC decision

 

Name of medicineRezolsta
INNdarunavir / cobicistat
Marketing-authorisation holderJanssen-Cilag International NV
More informationRezolsta: Pending EC decision

 

Name of medicineSuliqua
INNinsulin glargine / lixisenatide
Marketing-authorisation holdersanofi-aventis groupe
More informationSuliqua: Pending EC decision

 

Name of medicineTybost 
INNcobicistat
Marketing-authorisation holderGilead Sciences Ireland UC
More informationTybost: Pending EC decision

 

Name of medicineVenclyxto
INNvenetoclax
Marketing-authorisation holderAbbVie Deutschland GmbH & Co. KG
More informationVenclyxto: Pending EC decision

 

Withdrawal of initial marketing authorisation application

Name of medicineIdhifa
INNenasidenib
Marketing-authorisation holderCelgene Europe B.V. 
More informationIdhifa: Withdrawn application

 

Withdrawal of extension of indication

Name of medicineKeytruda
INNpembrolizumab 
Marketing-authorisation holderMerck Sharp & Dohme B.V.
More informationKeytruda: Withdrawn application

 

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