Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 28-30 April 2020

News 30/04/2020

Eight new medicines recommended for approval

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

The Committee recommended granting a marketing authorisation for Enerzair breezhaler, the first triple combination therapy for the treatment of asthma which includes an optional smart electronic sensor. Enerzair breezhaler consists of a fixed dose combination of three active substances (indacaterol / glycopyrronium / mometasone furoate) in capsules, to be administered using an inhaler. An optional digital sensor collects data on a patient’s use and sends them to an app on a smart phone or another suitable device. For more information, see the press release in the grid below.

The CHMP also adopted a positive opinion for Zimbus Breezhaler (indacaterol / glycopyrronium / mometasone furoate) which is a duplicate of Enerzair Breezhaler for the treatment of asthma.

The Committee recommended granting a marketing authorisation for Daurismo* (glasdegib) for the treatment of acute myeloid leukaemia, a cancer of a type of immature white blood cell called myeloid cells.

Reblozyl* (luspatercept) received a positive opinion from the CHMP for the treatment of adults with transfusion-dependent anaemia associated with myelodysplastic syndromes (diseases in which the body produces large numbers of abnormal blood cells) or beta-thalassaemia (a blood disorder that reduces the production of haemoglobin).  

The biosimilar medicine Insulin aspart Sanofi (insulin aspart) received a positive opinion for the treatment of diabetes mellitus.

The CHMP recommended granting a marketing authorisation for Cabazitaxel Accord (cabazitaxel), a hybrid medicine for the treatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen. 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.

Paliperidone Janssen-Cilag International (paliperidone), which was evaluated in an informed consent application, received a positive opinion for the treatment of schizophrenia. An informed consent application makes use of data from the dossier of a previously authorised medicine, with the marketing authorisation holder of that medicine giving consent for the use of their data in the application.

The generic medicine Fingolimod Accord (fingolimod) received a positive opinion for the treatment of relapsing-remitting multiple sclerosis with high disease activity.

Negative recommendation on new medicine following re-examination

The applicant for Hopveus (sodium oxybate) requested a re-examination of the Committee's negative opinion adopted at the October 2019 meeting. After considering the grounds for this request, the CHMP re-examined the initial opinion and confirmed its previous recommendation to refuse the granting of a marketing authorisation for this medicine, which was intended for the treatment of alcohol dependence.

For more information on this negative opinion, see the question-and-answer document in the grid below.

Nine recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for Braftovi, Cablivi, Carmustine Obvius, Ecalta, Harvoni, Kalydeco, Sovaldi, Taltz and Ultomiris.

The CHMP recommended the addition of a new pharmaceutical form (solution for injection) associated with a new strength and a new route of administration (subcutaneous injection into the abdomen) for Darzalex (daratumumab).

The Committee adopted a positive opinion recommending a new pharmaceutical form (sublingual film) associated with four new strengths for either sublingual or buccal use for Suboxone (buprenorphine / naloxone).

Outcome of review on ranitidine medicines

The CHMP recommended the suspension of all ranitidine medicines in the EU due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA). Ranitidine medicines are used for reducing levels of stomach acid in patients with conditions such as heartburn and stomach ulcers. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on animal studies. Available safety data do not show that ranitidine increases the risk of cancer, and any possible risk is likely to be very low. However, NDMA has been found in several ranitidine medicines above levels considered acceptable and there are unresolved questions about the source of the impurities.

For more information, see the public health recommendation in the grid below.

Outcome of review on fluorouracil medicines

The Committee recommended that patients should be tested for the lack of the enzyme dihydropyrimidine dehydrogenase (DPD) before starting cancer treatment with fluorouracil given by injection or infusion (drip) and related medicines containing capecitabine and tegafur. As treatment for severe fungal infections with flucytosine (another medicine related to fluorouracil) should not be delayed, testing patients for DPD deficiency before they start treatment is not required. Patients who completely lack DPD must not be given any fluorouracil medicines.

For more information, see the public health recommendation in the grid below.

Outcome of review on Picato

EMA has completed its review of Picato (ingenol mebutate), a gel for treating the skin condition actinic keratosis, and concluded that the medicine may increase the risk of skin cancer and that its risks outweigh its benefits. Picato is no longer authorised in the EU as the marketing authorisation was withdrawn on 11 February 2020 at the request of the company that marketed the medicine. For more information, see the public health recommendation in the grid below.

Agenda and minutes

The agenda of the April meeting is published on EMA's website. Minutes of the March 2020 CHMP meeting will be published in the coming weeks.

CHMP statistics

Key figures from the April 2020 CHMP meeting are represented in the graphic below.


* These products were designated as 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.

CHMP statistics: April 2020

 

Positive recommendations on new medicines

Name of medicineDaurismo
International non-proprietary name (INN)glasdegib
Marketing-authorisation applicantPfizer Europe MA EEIG
Therapeutic indicationTreatment of acute myeloid leukaemia
More informationDaurismo: Pending EC decision

 

Name of medicineEnerzair Breezhaler 
INNindacaterol / glycopyrronium / mometasone furoate
Marketing-authorisation applicantNovartis Europharm Limited
Therapeutic indicationMaintenance treatment of asthma in adults whose disease is not adequately controlled
More information

Enerzair Breezhaler: Pending EC decision

 

First triple combination therapy for asthma with optional electronic sensor

 

Name of medicineReblozyl
Common nameluspatercept 
Marketing-authorisation applicantCelgene Europe B.V.
Therapeutic indicationTreatment of adults with transfusion-dependent anaemia associated with myelodysplastic syndromes or beta-thalassaemia
More informationReblozyl: Pending EC decision

 

Name of medicineZimbus Breezhaler 
INNindacaterol / glycopyrronium / mometasone furoate
Marketing-authorisation applicantNovartis Europharm Limited
Therapeutic indication

Maintenance treatment of asthma in adults whose disease is not adequately controlled

More informationZimbus Breezhaler: Pending EC decision

 

Positive recommendation new generic medicine

Name of medicineFingolimod Accord 
INNfingolimod
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationTreatment of relapsing-remitting multiple sclerosis with high disease activity
More informationFingolimod Accord: Pending EC decision

 

Positive recommendation on new biosimilar medicine

Name of medicineInsulin aspart Sanofi 
INNinsulin aspart
Marketing-authorisation applicantsanofi-aventis groupe
Therapeutic indicationTreatment of diabetes mellitus
More informationInsulin aspart Sanofi​​​​​: Pending EC decision

 

Positive recommendation on new hybrid medicine

Name of medicineCabazitaxel Accord 
INNcabazitaxel
Marketing-authorisation applicantAccord Healthcare S.L.U.
Therapeutic indicationtreatment of patients with hormone refractory metastatic prostate cancer previously treated with a docetaxel-containing regimen
More informationCabazitaxel Accord​​​​​: Pending EC decision

 

Positive recommendation on new informed consent

Name of medicinePaliperidone Janssen-Cilag International 
INNpaliperidone
Marketing-authorisation applicantJanssen-Cilag International N.V.
Therapeutic indicationTreatment of schizophrenia
More informationPaliperidone Janssen-Cilag International​​​​​: Pending EC decision

 

Negative recommendation on new medicine following re-examination

Name of medicineHopveus
INNsodium oxybate
Marketing-authorisation applicantD&A Pharma
Therapeutic indicationTreatment of alcohol dependence
More informationHopveus​​​​​: Pending EC decision

 

Positive recommendations on extensions of indications

Name of medicineBraftovi 
INNencorafenib
Marketing-authorisation holderPierre Fabre Medicament
More informationBraftovi: Pending EC decision

 

Name of medicineCablivi
INNcaplacizumab
Marketing-authorisation holderAblynx N.V.
More informationCablivi: Pending EC decision

 

Name of medicineCarmustine Obvius 
INNcarmustine
Marketing-authorisation holderObvius Investment B.V.
More informationCarmustine Obvius: Pending EC decision

 

Name of medicineEcalta 
INNanidulafungin
Marketing-authorisation holderPfizer Europe MA EEIG
More informationEcalta: Pending EC decision

 

Name of medicineHarvoni 
INNledipasvir / sofosbuvir
Marketing-authorisation holderGilead Sciences Ireland UC
More informationHarvoni: Pending EC decision

 

Name of medicineKalydeco
INNIvacaftor
Marketing-authorisation holderVertex Pharmaceuticals (Ireland) Limited
More informationKalydeco: Pending EC decision

 

Name of medicineSovaldi
INNsofosbuvir
Marketing-authorisation holderGilead Sciences Ireland UC
More informationSovaldi: Pending EC decision

 

Name of medicineTaltz
INNixekizumab
Marketing-authorisation holderEli Lilly Nederland B.V.
More informationTaltz: Pending EC decision

 

Name of medicineUltomiris
INNravulizumab
Marketing-authorisation holderAlexion Europe SAS
More informationUltomiris: Pending EC decision

 

Important recommendations on new strengths, formulations or routes of administration

Name of medicineDarzalex
INNdaratumumab
Marketing-authorisation holderJanssen-Cilag International N.V.
More informationDarzalex​: Pending EC decision

 

Name of medicineSuboxone
INNbuprenorphine / naloxone 
Marketing-authorisation holderIndivior Europe Limited
More informationSuboxone: Pending EC decision

 

Public-health recommendations

Name of medicineFluorouracil and fluorouracil related substances (capecitabine, tegafur and flucytosine) containing medicinal products
INNcapecitabine, fluorouracil, tegafur, flucytosine
More informationEMA recommendations on DPD testing prior to treatment with fluorouracil, capecitabine, tegafur and flucytosine

 

Name of medicinePicato
INNingenol mebutate
More informationRisks of Picato for actinic keratosis outweigh benefits

 

Name of medicineRanitidine-containing medicinal products
INNranitidine
More informationSuspension of ranitidine medicines in the EU

 

Outcome of arbitration procedure

Start of re-examination of arbitration procedure

Other opinion

Name of medicineKeytruda
INNpembrolizumab
Marketing-authorisation applicantMerck Sharp & Dohme B.V.
More information PDF iconQuestions and answers on the use of Keytruda alone in non-small cell lung cancer with low levels of PD-L1

 

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