Ryzodeg would have further delayed a launch in the world’s biggest market. The U.S. Food and Drugs Administration (FDA) asked Novo to conduct the dedicated cardiovascular risk trial, known as DEVOTE, after refusing to approve Tresiba in 2013 because of worries it might be linked to
higher rates of heart attacks or strokes. Novo had previously said it
would decide during the first half of this year whether to submit interim or full trial results. Waiting for full
results would have jeopardized its aim of getting to market in 2016. Tresiba, an ultra-long-acting form of insulin that is also known as degludec, is seen as a crucial future growth driver for
the world’s top insulin maker as it battles to maintain market share in the face of stiff competition. Industry analysts forecast it will generate annual sales of $2.2 billion by 2020, according to consensus estimates compiled by Thomson Reuters Cortellis. Novo noted that results from an interim trial analysis carried a higher level of un
certainty than final study data. “Accordingly, the relative risk estimat港台神算打一生肖 e that has been derived from the int
erim analysis is thus only an indication of
the final trial results,” it said in a statement. Following the submission, the FDA is expected to communicate either its acceptance of the filing or issue a so-called incomplete response letter within a month.