Germany's IQWiG finds no added benefit for Komboglyze or for Pixuvri

In an early benefit assessment under Germany’s Act on the Reform of the Market for Medicinal Products (AMNOG), the Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether the fixed combination of the drugs saxagliptin and metformin, marketed by US drugmaker Bristol-Myers Squibb (NYSE: BMY) and Anglo-Swedish pharma firm AstraZeneca (LSE: ANZ) as Komboglyze and Onglyza, offers an added benefit versus the current standard treatment for diabetes. The agency also examined Cell Therapeutics’ (Nasdaq: CTIC) non-Hodgkin lymphomas treatment Pixuvri (pixantrone).

Such an added benefit cannot be derived from the dossier for Komboglyze, however, as the manufacturer did not submit any relevant data, the IQWiG concluded. The opinion comes just as there are questions over the GLP-1 new class of diabetes therapies, into which saxagliptin falls, linking them with an increased risk of pancreatitis (The Pharma Letter February 26).

Komboglyze has been approved in Germany since November 2011 for the treatment of type 2 diabetes mellitus and, globally, generated sales of $709 million for B-MS in 2012, a rise of 50% on the previous year.