The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for drugs to treat growth hormone deficiency in children, type 2 diabetes and associated chronic kidney disease (CKD), and hyperphenylalaninemia.
At its December meeting, positive opinions were adopted for the new drugs somatrogon (Ngenia, Pfizer Europe) and finerenone (Kerendia, Bayer AG) and generic versions of sitagliptin hydrochloride monohydrate/metformin hydrochloride (Mylan Ireland Limited) and sapropterin (Dipharma BV).
New Drug: Finerenone
Finerenone is indicated for the treatment of CKD (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. It is a nonsteroidal, selective antagonist of the mineralocorticoid receptor that works by reducing expression of proinflammatory and profibrotic mediators.
Available as 10-mg and 20-mg film-coated tablets, finerenone delays CKD progression in adults with type 2 diabetes. The most common side effects are hyperkalaemia, decreased estimated glomerular filtration rate, and hypotension.
Finerenone was approved for slowing CKD associated with type 2 diabetes in the US in July.
New Drug: Somatrogon
The injectable somatrogon will be indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient growth hormone secretion. It should be prescribed by physicians experienced in treating pediatric patients with that condition.
The long-acting once-weekly recombinant human growth hormone will be available as 24 mg/1.2 mL and 60 mg/1.2 mL solutions for injection. In studies, somatrogon led to long-term improvements of growth-related parameters, including annualized height velocity and height standard deviation score, without excessive acceleration of bone maturation in pediatric treatment-naive growth hormone–deficient patients.
The most common side effects were injection site reactions, headache, and pyrexia.
Generic Version of Sitagliptin/Metformin
The generic formulation of combined sitagliptin/metformin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes inadequately controlled on maximal tolerated dose of metformin alone or who are already being treated with the branded sitagliptin/metformin combination (Janumet, Merck).
It may also be used for triple therapy in patients who don’t achieve target glycemia with metformin plus either a sulfonylurea, a peroxisome proliferator-activated receptor gamma (PPARg) agonist (eg, pioglitazone), or insulin.
The combination sitagliptin/metformin hydrochloride will be available as 50 mg/850 mg and 50 mg/1000 mg film-coated tablets.
Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that increases levels of active incretin hormones, leading to enhanced glucose-dependent insulin secretion and reduced glucagon release. Metformin works mainly by inhibiting glucose production and reducing its absorption in the gut.
Generic Formulation: Sapropterin
The generic version of Kuvan (BioMarin RareConnections), Sapropterin Dipharma, is indicated for treatment of hyperphenylalaninaemia (HPA) in adults and children of all ages with phenylketonuria (PKU) or with tetrahydrobiopterin (BH4) deficiency who have been shown to be responsive such treatment. It must be initiated and supervised by a physician experienced in treating PKU and BH4 deficiency.
Sapropterin is a synthetic version of the naturally occurring tetrahydrobiopterin, a cofactor of hydroxylases for phenylalanine, tyrosine, and tryptophan. It will be available as powder for oral solution (100 and 500 mg) and soluble tablets (100 mg).
All of the products are pending final European Medicines Agency approval, which is normally a formality within 60 days.
Miriam E. Tucker is a freelance journalist based in the Washington DC area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She is on Twitter @MiriamETucker.
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