EMA's CHMP gives Gamifant a second thumbs down; approves five new medicines

Regulatory NewsRegulatory News | 13 November 2020 |  By 

In its November meeting, a committee of the European Medicines Agency gave its second thumbs down to the monoclonal antibody Gamifant (emapalumab), confirming a July 2020 negative opinion on the Novimmune SA drug.
The US FDA approved Gamifant for pediatric use in primary hemophagocytic lymphohistiocytosis in November 2018; this was the same indication for which EMA has twice declined authorization.
EMA’s human medicines committee (CHMP) had positive recommendations on the first go for four new medicines: the glaucoma medication Roclanda (latanoprost/netarsudil; Aerie Pharmaceuticals), the antiviral Xofluza (baloxavir marboxil; Roche Registration GmbH), the cancer therapy combination Phesgo (pertuzumab / trastuzumab; Roche), and the biosimilar Onbevzi (bevacizumab; Samsung Bioepis).
One additional medicine received a positive recommendation on re-examination. Elzonris (tagraxofusp; Stemline Therapeutics) was given a favorable decision at the November CHMP meeting after an initial refusal in July 2020, with authorization restricted to an indication for use in exceptional circumstances for patients who had not been treated for the rare form of acute myeloid leukemia for which authorization was initially sought.
Six medicines received favorable recommendations for extended indication: Kyprolis, Pradaxa, Tivicay, Trimbow, Xarelto and Xyrem.
In other CHMP activity, the committee aligned the recommendations for limiting nitrosamine impurities in sartan medicines with the recommendations it had already issued for other medicines. Limitations on nitrosamine impurities will now apply to the finished drug form rather than to active ingredients.
CHMP also made a determination that ulipristal acetate-containing medications (Esmya and its generics) are now restricted for use only for premenopausal women with uterine fibroids in whom embolization or other surgical procedures have not been effective. The restriction was imposed because of concerns for serious liver injury from the medicine.


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