Actos suspension could shake up a market already in transition
This article was originally published in Scrip
Antidiabetic drug Actos was suspended in France due to a link with bladder cancer. Will other countries follow and how will this impact the oral antidiabetics market?
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Dapagliflozin, the most advanced candidate in the novel SGLT-2 inhibitor antidiabetic class, was the subject of a complete response letter from the FDA, co-developers Bristol-Myers Squibb and AstraZeneca announced on 19 January 2012. The letter was not unexpected, given a negative 9-6 vote from an FDA Advisory Committee in July 2011 which revealed concerns about possible increased risks of breast and bladder cancers seen in the aggregated Phase II and Phase III trial data, as well as a case of probable drug-induced liver injury (scripintelligence.com, 21 July 2011).
The decision by Amylin and Lilly to end their co-development and marketing deal covering exenatide antidiabetic products potentially opens the door to other partners that might be more committed to driving ex-US sales. The divorce was prompted by Lilly's recent link up with Boehringer Ingelheim for a competing product.
In September 2011 Boehringer Ingelheim and Eli Lilly announced a delay to the German launch of their novel DPP-IV inhibitor Tradjenta (linagliptin; sold in the EU as Trajenta) because of the anticipated difficulty in agreeing a suitable price with the German regulators. In Germany, most of the cost of care for most of the population is covered by a range of sickness funds funded by statutory health insurance. Furthermore, a state body - IQWiG (the Institute for Quality and Efficiency in Health Care) - is involved in setting reimbursement pricing for new medications.