The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended four medicines for approval at its May 2019 meeting.
The Committee recommended granting a marketing authorisation for Univar’s Cufence (trientine dihydrochloride) for the treatment of Wilson’s disease, a drug that was designated as an orphan medicine during its development.
The European advisory group also granted a positive opinion for Novartis’ LysaKare (arginine/lysine) for protecting the kidneys against radiation during radioactive therapy with lutetium oxodotreotide.
In addition to these, two generic medicines intended for the treatment and prevention of fungal infections received a positive opinion.
Posaconazole Accord (posaconazole), intended for the treatment and prevention of fungal infections, and Posaconazole AHCL (posaconazole), both of which are a generic of Noxafil, which has been authorised in the European Union since 25 October 2005.
Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections.
The committee also dished out some negative opinions, starting with the refusal of a marketing authorisation for Emmaus’s Xyndari (glutamine), a drug that was expected to be used to treat sickle cell disease, an inherited form of anemia. The decision goes against a recent US Food and Drug Administration (FDA) decision to approve the treatment.
There was also a negative recommendation on TLC Biopharmaceuticals' Doxolipad (doxorubicin), following re-examination. 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 breast and ovarian cancer.