Eleven new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the European Union.

The CHMP adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis is not used, cannot be used or is not available. Placed in the vagina, the ring slowly releases the antiretroviral medicine dapivirine over a period of 28 days.

This is the eleventh medicine recommended by EMA under EU Medicines for all (EU-M4All), a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the EU under Article 58 of Regulation (EC) No 726/2004. For more information, see the press release in the grid below.

The Committee recommended granting a conditional marketing authorisation for Blenrep* (belantamab mafodotin), a new antibody-drug conjugate for adult patients with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody. Blenrep benefited from the support of the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs. For more information, see the press release in the grid below.

The CHMP recommended granting a marketing authorisation for Adakveo* (crizanlizumab), for the prevention of recurrent vaso-occlusive crises (when blood vessels are blocked by abnormal red blood cells, restricting the flow of blood to an organ) in patients with sickle cell disease.

The CHMP adopted a positive opinion for Arikayce liposomal* (amikacin), for the treatment of non-tuberculous mycobacterial lung infections caused by Mycobacterium avium Complex in adults with limited treatment options who do not have cystic fibrosis.

The Committee recommended granting a conditional marketing authorisation for Ayvakyt* (avapritinib), for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours harbouring the platelet-derived growth factor receptor alpha D842V mutation.

The Committee adopted a positive opinion for Calquence* (acalabrutinib) for the treatment of chronic lymphocytic leukaemia, a type of cancer affecting white blood cell called lymphocytes.

Jyseleca (filgotinib) received a positive opinion for the treatment of rheumatoid arthritis.

The CHMP recommended granting a marketing authorisation for Zynrelef (bupivacaine / meloxicam) for the treatment of post-operative pain.

The biosimilar medicine Equidacent (bevacizumab) received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

The CHMP recommended granting marketing authorisations for two generic medicinesArsenic trioxide medac (arsenic trioxide), for the treatment of acute promyelocytic leukaemia (blood cancer) and Fampridine Accord (fampridine), intended to improve walking of adult patients suffering from multiple sclerosis with walking disability.

Negative recommendations on new medicines

The CHMP adopted negative opinions recommending the refusal of marketing authorisations for Elzonris (tagraxofusp) and Gamifant (emapalumab).

Elzonris was expected to be used for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive type of acute myeloid leukaemia (blood cancer). Gamifant was expected to be used to treat primary haemophagocytic lymphohistiocytosis (a genetic disease characterised by an overactive immune system) in children under 18 years of age.

For more information on these negative opinions, see the question-and-answer documents in the grid below.

Nine recommendations on extensions of therapeutic indication

The Committee recommended extensions of indication for CrysvitaHyQviaImbruvicaImfinziKalydecoLatudaNovoThirteenPrezista and Shingrix.

Change to non-prescription status

The CHMP recommended a change in classification status from prescription to non-prescription for Fortacin (lidocaine / prilocaine), a medicine to treat men with primary (lifelong) premature ejaculation.

Outcome of review on medicines tested by Panexcell Clinical Laboratories

The Committee recommended the suspension of the marketing authorisations of generic medicines tested by Panexcell Clinical Laboratories Priv. Ltd at its site in Mumbai, India. The recommendation comes after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies, which are used to show that a generic medicine produces the same amount of active substance in the body as the reference medicine.

Outcome of review on Yondelis

The CHMP recommended that the use of Yondelis (trabectedin) in treating ovarian cancer remains unchanged following a review of a study that investigated Yondelis as a third line treatment in patients with ovarian cancer. However, the study results will be included in the medicine’s product information to provide healthcare professionals with the most up-to-date information.

Start of referral

The Committee started a review of the results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. The review aims to provide an opinion on the results of the study and in particular the potential use of dexamethasone for the treatment of adults with COVID-19.

Withdrawals of applications

Applications for initial marketing authorisations for Rayoqta (abicipar pegol) and Abilify MyCite (aripiprazole) have been withdrawn.

Rayoqta was expected to be used to treat age-related macular degeneration, a disease which affects the central part of the retina (called the macula) at the back of the eye and causes gradual loss of vision. Abilify MyCite was expected to be used to treat schizophrenia and bipolar I disorder.

Posted on the EMA website on 24 July 2020