Glaxo’s Diabetes Drug Recommended by EU Regulator

GlaxoSmithKline Plc (GSK) 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 adult patients with Type 2 diabetes, Glaxo said in a statement today.

Clinical trials on albiglutide showed mixed results on its effectiveness and side effects. It hasn’t demonstrated benefits over Takeda Pharmaceutical Co.’s Actos or Novo Nordisk A/S (NOVOB)’s Victoza, two leading treatments for diabetes. Glaxo has said albiglutide’s once-weekly dosing would make the drug more convenient for patients compared with existing once-daily treatments.

Sales of albiglutide may reach $218 million by 2016, according to the average of seven analyst estimates compiled by Bloomberg. Glaxo is seeking a partner in the U.S. to help market the drug.

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.

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.

To contact the reporter on this story: Makiko Kitamura in London at mkitamura1@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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