Four new medicines approved by EMA
The European Medicines Agency (EMA) has approved four new medicines at its January meeting, getting 2023 off to a low-key start.
The Agency’s key human medicines committee (CHMP) recommended granting a marketing authorisation for Sotyktu (deucravacitinib) – a medicine for the treatment of moderate to severe plaque psoriasis in adults, a skin disease causing red, scaly patches.
The committee adopted positive opinions for three generic medicines:
- Dapagliflozin Viatris (dapagliflozin) for the treatment of type 2 diabetes mellitus, heart failure and chronic kidney disease.
- Sitagliptin/Metformin hydrochloride Sun (sitagliptin/metformin hydrochloride) for the treatment of type 2 diabetes mellitus.
- Tolvaptan Accord (tolvaptan) to treat adults with low blood sodium levels caused by the syndrome of inappropriate antidiuretic hormone secretion.
Recommendations on extensions of therapeutic indication for seven medicines that are already authorised in the EU: Byfavo, Dupixent, Nubeqa, Reblozyl, Trecondi, Trulicity and Wakix.