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.

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.

Nine recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for BraftoviCabliviCarmustine ObviusEcaltaHarvoniKalydecoSovaldiTaltz 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.

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.

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.

Posted on the EMA website on 30 April 2020