Sanofi-Aventis has received a major boost with the news that regulators in the USA have approved its cardiovascular drug Multaq and a launch across the Atlantic will take place over the summer.

The US Food and Drug Administration has given the green light to Multaq (dronedarone) to help reduce the risk of cardiovascular hospitalisation for patients with atrial fibrillation or atrial flutter. The approval is based on data from five clinical studies involving 6,300 patients, over half of whom were on Multaq. One of the trials, Athena, showed that the drug cut the total number of hospital days in patients with AF by 28% compared to placebo and slashed the total length of time spent in the hospital for heart-related reasons by 35%.

The approval was expected as the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10 to three in favour of Multaq in March. The company noted that to ensure the drug gets to the right patients, it is launching a risk mitigation programme for patients “in a therapeutic area that has seen few new treatment options in the last twenty years”, said Sanofi R&D head Marc Cluzel.

Sanofi has predicted annual sales of more than 1 billion euros for Multaq, though most analysts, who note that the drug is the first to come out of Sanofi’s pipeline for a long time, believe this estimate is on the conservative side.

Inconsistencies in Lantus analysis
Meantime, shares in Sanofi rose sharply yesterday after regulators in the USA questioned the findings of four studies that suggested a link between the diabetes drug Lantus and cancer.

The company’s stock has been badly hit in the last week since three of those four studies, published in the journal Diabetologia which suggest an increased risk for cancer associated with use of Lantus (insulin glargine). However the FDA noted that the duration of patient follow-up in all four studies “was shorter than what is generally considered necessary to evaluate for cancer risk from drug exposure”.

Furthermore, the agency said that “inconsistencies in findings within and across individual studies raise concerns as to whether an association between the use of insulin glargine and cancer truly exists”. Additionally, the FDA states that “differences in patient characteristics across the treatment groups may have contributed to a finding of increased cancer risk”.

The FDA went on to say that “based on the currently available data”, it recommends that patients should not stop taking Lantus without consulting a doctor. It is, however, currently reviewing “many sources of safety data” including the newly-published observational studies “to better understand the risk, if any, for cancer associated with use of Lantus”. The agency’s European counterparts are carrying out a similar review

Discussions are ongoing between FDA and Sanofi as to whether any additional studies evaluating the safety and efficacy of Lantus will need to be performed. However the firm believes that there is no case to answer.

Sanofi chief executive Chris Viehbacher said that “major scientific questions” have been posed “for over two decades as to the role of insulin and diabetes and obesity and cancer”. However all the experts the company has been talking to “would agree, and have said very clearly”, that the four studies published in Diabetologia “do not even begin to answer these questions and point out significant limitations of these studies”.

The FDA’s comments helped Sanofi shares climb 3.1% to 43.15 euros last night, after they had fallen around 13% since last Friday. All the furore has helped the stock of Novo Nordisk which noted that there was no cancer risk noted with its rival product Levemir (insulin detemir). The Danish drugmaker said that “a large body of clinical trials and in-market experience support that Novo Nordisk insulin analogues have an excellent safety profile”.