EU OKs Difelikefalin for CKD-Associated Pruritus, Generic Diabetes Meds
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for a new drug for pruritus associated with chronic kidney disease (CKD), two biosimilar insulins for diabetes, and a generic version of the DPP-4 inhibitor sitagliptin for type 2 diabetes at its most recent meeting in February.
Difelikefalin (Kapruvia, Vifor Fresenius Medical Care Renal Pharma) was recommended for approval for the treatment of moderate-to-severe pruritus associated with CKD. The selective agonist of the kappa-opioid receptor will be available as a 50-µg/mL solution for injection and can reduce itching and produce immunomodulatory effects when activated, according to information from the EMA.
It was approved in the United States last August for the treatment of moderate-to-severe pruritus associated with CKD in adults undergoing hemodialysis.
And two biosimilar insulins were given the green light for diabetes. Human insulin (rDNA) (Inpremzia, Baxter Holding), a fast-acting insulin for injection highly similar to the reference product Actrapid (human insulin), and insulin aspart (Truvelog Mix 30, Sanofi-Aventis), a biosimilar of another rapid-acting insulin, NovoRapid Penfill and NovoRapid FlexPen, which acts within 15 minutes.
The CHMP also issued a positive opinion for Sitagliptin Accord (sitagliptin, Accord Healthcare) for type 2 diabetes, a generic form of the branded product Januvia (Merck), first approved in the EU in 2007.
Sitagliptin Accord will be available as an oral therapy as 25-mg, 50-mg, and 100-mg film-coated tablets and is indicated for mono-, dual, or triple therapy.
Detailed recommendations for the use of these drugs will be described in the summary of product characteristics, which will be published in the European public assessment report and made available after marketing authorization has been granted by the European Commission, normally a formality within 60 days of the positive opinion.
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