Tuesday, November 2, 2021

Six new medicines leap towards EU approval




The EMA’s human medicines committee (CHMP) recommended six medicines for approval at its November 2020 meeting.

Roche’s Phesgo (pertuzumab/trastuzumab) was endorsed as a treatment for early and metastatic breast cancer.

According to the CHMP, the benefit of Phesgo is that it is administered as a subcutaneous, fixed-dose combination of pertuzumab and trastuzumab, “offering patients a less invasive and faster administration as a single product, compared to the current administration of the approved intravenous pertuzumab and subcutaneous trastuzumab formulations”.

A positive opinion was also adopted for the Swiss drug giant’s Xofluza (baloxavir marboxil), for the treatment and post-exposure prophylaxis of uncomplicated influenza.

Aerie Pharmaceuticals Ireland’s Roclanda (latanoprost/netarsudil) was backed 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.

Samsung Bioepis’ biosimilar Onbevzi (bevacizumab) won CHMP backing 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 Committee noted that Onbevzi has comparable quality, safety and efficacy to Avastin (bevacizumab), which was authorised in the EU on 12 January 2005.

The CHMP also recommended approving the marketing authorisation for Stemline Therapeutics’ 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, it recommended approval under exceptional circumstances but for a restricted indication for first-line treatment.

The CHMP also issued six recommendations on extensions of indications for Kyprolis, Pradaxa, Tivicay, Trimbow, Xarelto and Xyrem.

On the downside, the Committee stuck with a negative recommendation on Swedish Orphan Biovitrum’s Gamifant (emapalumab). Having re-examined the application, the CHMP felt that safety concerns had been addressed, but that questions remain over efficacy.

The drug 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.



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