As expected, European regulators have given the green light to expanded use for Amylin Pharmaceuticals and soon-to-be ex-partner Eli Lilly's diabetes drug Byetta.
The European Commission has granted marketing authorisation for twice-daily Byetta (exenatide) as an adjunctive therapy to basal insulin, with or without metformin and/or Takeda's Actos (pioglitazone) for the treatment of type 2 diabetes in adults who have not achieved adequate glycaemic control with these agents. The thumbs-up comes just over a month after the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval for the combo, which was okayed in the USA last autumn.
The expanded approval "provides a new option for the many patients with type 2 diabetes who are not achieving treatment goals", said Christian Weyer, Amylin's R&D chief. He noted that in a clinical trial, patients using fixed-dose Byetta with titrated basal insulin "achieved better postprandial and overall glycaemic control, without weight gain or an increased risk of hypoglycaemia", compared to those on titrated basal insulin alone.
In November, Amylin and Eli Lilly agreed to dissolve their pact (signed in 2002) for Byetta, a glucagon-like peptide-1 receptor agonist, and its once-weekly successor Bydureon. The former had questioned Lilly's commitment to the drugs after it signed a deal with Boehringer Ingelheim, including a marketing link-up for the German firm's oral dipeptidyl peptidase-4 inhibitor Tradjenta (linagliptin).
As part of the transition plan outside the USA, Amylin will assume responsibility for exenatide product commercialisation on a market-by-market basis by the end of 2013 and will work with Lilly during that period. For non-US territories, Amylin intends to work with "one or more partners…to maximise the global potential of this innovative molecule".