Five new medicines recommended for approval
EMA’s human medicines committee (CHMP) recommended five medicines for approval at its November 2020 meeting.
The Committee recommended granting a marketing authorisation for Phesgo (pertuzumab / trastuzumab) for the treatment of early and metastatic breast cancer.
The CHMP adopted a positive opinion for Roclanda (latanoprost / netarsudil) for the reduction of elevated intraocular pressure (IOP) in adult patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin or netarsudil provides insufficient IOP reduction.
Xofluza (baloxavir marboxil) received a positive opinion from the CHMP for the treatment and post-exposure prophylaxis of uncomplicated influenza.
The biosimilar medicine Onbevzi (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.
Positive recommendation on a new medicine following re-examination
The CHMP recommended approving the marketing authorisation for Elzonris* (tagraxofusp), for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive type of acute myeloid leukaemia (blood cancer). The Committee had initially refused the application in July 2020 for Elzonris to be used for the treatment of BPDCN regardless of whether patients had been previously treated with other medicines or not. After re-examination, the CHMP recommended that marketing authorisation under exceptional circumstances could be granted but for a restricted indication in patients who had not yet received any treatment for BPDCN (first-line treatment).
Negative recommendation on a new medicine following re-examination
The applicant for Gamifant (emapalumab) requested a re-examination of the Committee’s negative opinion adopted at the July 2020 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 primary haemophagocytic lymphohistiocytosis (a genetic disease characterised by an overactive immune system) in children under 18 years of age.
Six recommendations on extensions of therapeutic indication
The Committee recommended extensions of indication for Kyprolis, Pradaxa, Tivicay, Trimbow, Xarelto and Xyrem.
Nitrosamines: EMA aligns recommendations for sartans with those for other medicines
The CHMP has aligned recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines. The main change concerns the limits for nitrosamines, which previously applied to the active ingredients but will now apply instead to the finished products (e.g. tablets). These limits, based on internationally agreed standards (ICH M7(R1)), should ensure that the excess risk of cancer from nitrosamines in any sartan medicines is below 1 in 100,000 for a person taking the medicine for lifelong treatment.
Outcome of review on medicines containing ulipristal acetate 5 mg
The Committee recommended restricting use of medicines containing ulipristal acetate 5 mg (Esmya and generic medicines) as a result of cases of serious liver injury. The medicines can now only be used to treat uterine fibroids in premenopausal women for whom surgical procedures (including uterine fibroid embolisation) are not appropriate or have not worked. The medicines must not be used for controlling symptoms of uterine fibroids while awaiting surgical treatment.
Withdrawals of applications
Three applications for initial marketing authorisations were withdrawn: Puldysa (idebenone), for the treatment of Duchenne muscular dystrophy; Roctavian (valoctocogene roxaparvovec), for the treatment of severe haemophilia A; and Tibsovo (ivosidenib), for the treatment of acute myeloid leukaemia, a cancer of white blood cells.
* 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.
