Glaxo’s Diabetes Drug Recommended by EU RegulatorMakiko Kitamura
GlaxoSmithKline Plc said Eperzan, its treatment for Type 2 diabetes, was recommended for approval by the European Union’s drug regulator.
The once-weekly medicine, also known as albiglutide, was recommended by the European Medicines Agency as a treatment to improve glycemic control in adults with Type 2 diabetes, Glaxo said in a statement today.
Clinical trials showed mixed results on albiglutide’s effectiveness and side effects. It hasn’t demonstrated benefits over Takeda Pharmaceutical Co.’s Actos or Novo Nordisk A/S’s Victoza, two leading diabetes treatments. Glaxo has said albiglutide’s once-weekly dosing would make the drug more convenient for patients compared with existing daily treatments.
“Eperzan’s commercial potential is still likely to be limited,” said Sam Fazeli, a Bloomberg Industries analyst in London.
Sales of albiglutide may reach $218 million by 2016, according to the average of seven analyst estimates compiled by Bloomberg.
Glaxo has also filed the drug with the U.S. Food and Drug Administration, which extended the review period by three months to April 15, the company said in August. Glaxo is seeking a partner in the U.S. to help market the drug.
The European agency’s recommendations are the final stage before the European Commission, the EU’s executive arm, approves or rejects a drug for sale to patients in the 28-nation region.