Ten medicines recommended for approval, including two orphans

The European Medicines Agency’s Committee for Medicinal Products for Human Use(CHMP) recommended ten medicines for approval, including two orphan medicines, at its November 2017 meeting.

The CHMP recommended granting a marketing authorisation for Jorveza (budesonide) to treat eosinophilic esophagitis, a rare inflammatory condition of the oesophagus. This medicine was reviewed under EMA’s accelerated assessment mechanism, reserved for medicines of major public health interest. Jorveza has an orphan designation.

The Committee recommended granting a marketing authorisation for Prevymis (letermovir), an antiviral medicine that prevents cytomegalovirus reactivation and disease in patients who receive immunosuppressant medicines following an allogeneic haematopoietic stem cell transplant. Prevymis has an orphan designation.

The CHMP recommended granting a marketing authorisation for Ocrevus (ocrelizumab), for the treatment of adult patients with relapsing multiple sclerosis (RMS) and early primary progressive multiple sclerosis (PPMS).

Adynovi (rurioctocog alfa pegol) received a positive opinion for the treatment and prophylaxis of bleeding in patients 12 years and above with haemophilia A.

The CHMP adopted a positive opinion for Fasenra (benralizumab) for the treatment of severe eosinophilic asthma.

Intrarosa (prasterone) received a positive opinion for the treatment of vulvar and vaginal atrophy in postmenopausal women.

One biosimilar medicine was recommended for approval by the Committee: Mvasi(bevacizumab) 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.

Three generic medicines received a positive opinion from the CHMPDarunavir Krka(darunavir) and Darunavir Krka d.d. (darunavir), both for the treatment of human immunodeficiency virus (HIV-1) infection; and Fulvestrant Mylan (fulvestrant), for the treatment of locally advanced or metastatic breast cancer.

Outcome of re-examination of two negative recommendations

The applicants for Fanaptum (iloperidone) and Onzeald (etirinotecan pegol) requested re-examinations of the Committee’s negative opinions for these medicines adopted at the July 2017 meeting. After considering the grounds for these requests, the CHMP re-examined the initial opinions and confirmed its previous recommendations to refuse the granting of marketing authorisations for these medicines.

Four recommendations on extensions of therapeutic indication

The Committee recommended extensions of indications for AdcetrisGenvoyaNplate and Orkambi.

Outcome of review on Zinbryta

The CHMP concluded its review of the multiple sclerosis medicine Zinbryta(daclizumab) and confirmed further restrictions to reduce the risk of serious liver damage.

Withdrawals of applications

Applications for initial marketing authorisations for Kyomarc (bevacizumab) and Plivensia (sirukumab) have been withdrawn.

Kyomarc was intended to be used to treat cancer of the colon or rectum, breast cancer, non-small cell lung cancer, kidney cancer, cervical cancer, and cancer of the ovary, the fallopian tube, or the peritoneum.

Plivensia was intended to be used to treat rheumatoid arthritis.

An application to extend the use of Keytruda (pembrolizumab) in metastatic non-squamous NSCLC in combination with chemotherapy has also been withdrawn.

Posted on the EMA website on 10 November 2017