Diabetes drug dapagliflozin (FORXIGA) off the market: AstraZeneca and Bristol-Myers Squibb withdrew the diabetes drug dapagliflozin (FORXIGA) from the German market on December 15, 2013, the harm/benefit balance of which we had evaluated as negative in January 2013 (a-t 2013; 44: 1-3). The reason for this move was the Federal Joint Committee's evaluation of the SGLT** 2 inhibitor, as it could not see any additional benefits for the approved indication in the treatment of patients with type 2 diabetes. As a result, the manufacturers and the National Association of Statutory Health Insurance Funds were unable to agree upon a reimbursement price (1). Dapagliflozin is, after the dipeptidyl peptidase-4 (DPP-4) inhibitor linagliptin (TRAJENTA; a-t 2011; 42: 73-4) and the insulin analogue degludec (TRESIBA), the third diabetes drug to either be withdrawn from the market or not even to be launched in the first place, due to their benefit assessment within the framework of the AMNOG (Pharmaceutical Market Restructuring Act). As in the case of dapagliflozin, there were no additional benefits recognised for linagliptin (2). For degludec, the supplier Novo Nordisk had not expected a positive result from the outset and, for this reason the drug was never launched in order to prevent price pressure in other countries (3). In the USA, approval of the insulin analogue was refused due to concerns about its safety. However, dapagliflozin was given approval by the FDA in a second attempt at the beginning of January 2014, although this was with considerable constraints, amongst others the need for clarification of the potential bladder cancer risk (4). In Germany it can be sold until the current supply is exhausted (1). We continue to advise against prescribing it, -Ed.

1

AstraZeneca: press release, 13 Dec. 2013; http://www.a-turl.de/?k=eewa

2

GKV-Spitzenverband: Erstattungsbetragsverhandlungen nach ? 130b SGB V: Linagliptin, as at June 2013; http://www.a-turl.de/?k=olit

3

BRUCE, F.: Scrip 30 August 2013: 7

4

FDA: press release 8 Jan. 2014; http://www.a-turl.de/?k=efel

*

Previous version published online on 18 December 2013 as blitz-a-t.

**

SGLT = Sodium Glucose Co-Transporter