Nine therapies spanning a range of diseases have been recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use, including three biosimilars.
First up, marketing authorisation has been recommended for CSL Behring's Afstyla (lonoctocog alfa) for the prevention and treatment of bleeding in patients of all ages with haemophilia A.
According to the regulator, the benefits with Afstyla are its ability to prevent and control bleeding when used on demand and used for surgical procedures as seen in clinical trials in adult and paediatric patients with haemophilia A, while the most common side effects are hypersensitivity, dizziness, paraesthesia, rash and pyrexia. The drug was approved in the US in May.
Gilead's Vemlidy (tenofovir alafenamide) has received a positive opinion from the CHMP for the treatment of chronic hepatitis B.
The drug has been shown to achieve a sustained antiviral response in treatment-naive and treatment-experienced patients and, according to the Committee, has low impact on renal safety and bone mineral density compared to the licensed tenofovir disoproxil.
Novo Nordisk's Fiasp (insulin aspart) is being endorsed as a treatment of diabetes type I and II, as the bolus component of basal-bolus therapy in combination with basal insulin and for continuous subcutaneous insulin infusion via an insulin pump.
The fast-acting insulin analogue is absorbed more rapidly by the body and can therefore act faster than human insulin, facilitating uptake of glucose into skeletal muscle and fat tissue, and by inhibiting glucose output from the liver.
Sanofi-Aventis' Suliqua (insulin glargine/lixisenatide) was recommended for approval for the treatment of type II diabetes.
Suliqua is a fixed-ratio combination of insulin glargine, a basal insulin analogue, and lixisenatide, a glucagon-like peptide 1 (GLP-1) receptor agonist. Insulin glargine binds specifically to the human insulin receptor while lixisenatide acts via enhancing glucose-dependent insulin secretion and reducing glucagon release.
Three biosimilars were put forward by the Committee: MSD's Lusduna (insulin glargine) for the treatment of diabetes; and STADA Arzneimittel's Movymia and Gedeon Richter's Terrosa - which both contain teriparatide - for the treatment of osteoporosis.
Two generic medicines manufactured by Mylan were also given the nod - Darunavir Mylan (darunavir) for the treatment of human immunodeficiency virus (HIV-1) infection and Tadalafil Generics (tadalafil) for pulmonary arterial hypertension.