The European Commission (EC) has approved Takeda’s Entyvio (vedolizumab) to treat adults with ulcerative colitis and Crohn’s disease and Boehringer Ingelheim/Lilly’s Jardiance (empagliflozin), which adds to the growing list of treatments for type 2 diabetes.
The approvals cover the European Union and come two months after scientific advisers at the European Medicines Agency (EMA) backed both products, and the same week that Entyvio was approved by the US FDA.
As per this recommendation, Entyvio is approved to treat patients with ulcerative colitis and Crohn’s disease who cannot tolerate or who respond poorly to conventional therapy or a tumour necrosis factor (TNF) antagonist such as J&J’s Remicade (infliximab)
Both conditions are types of inflammatory bowel disease and are thought to affect more than two million people in Europe, potentially offering a large market to Takeda despite the limited approval.
Entyvio – a humanised monoclonal antibody – marks Takeda’s first step into inflammatory bowel disease, and has been cited by the company as a key part of its growth plans.
Data from late-stage trials back these ambitions, demonstrating the drug’s effectiveness in improving remission rates.
Meanwhile, Boehringer and Lilly also celebrated obtaining EU marketing authorisation for their diabetes treatment Jardiance – the latest in a new class of drugs called SGLT-2 inhibitors to win approval.
These treatments work independently of insulin by blocking the re-absorption of glucose into the bloodstream, causing it to be removed via the urine.
SGLT-2 inhibitors already on the market in Europe include Johnson & Johnson’s Invokana (canagliflozin) and AstraZeneca’s Forxiga (dapagliflozin).
Both these products are also available as combination treatments with metformin in versions called Vokanamet (Invokana and metformin) and Xigduo (Forxiga and metformin).
The EC approval gives Boehringer and Lilly and a chance to catch up on their rivals and a combination of Jardiance and metformin is also in the works.