(Adds further details on trial, sales forecast)
(Reuters) - Denmark's Novo Nordisk saidon Thursday it had decided to submit interim analysis data froma clinical trial of its crucial new insulin drug Tresiba to U.S.regulators within the next month.
The decision is likely to be a relief to investors, since adecision not to file on Tresiba and the related drug Ryzodegwould have further delayed a launch in the world's biggestmarket.
The U.S. Food and Drugs Administration (FDA) asked Novo toconduct the dedicated cardiovascular risk trial, known asDEVOTE, after refusing to approve Tresiba in 2013 because ofworries it might be linked to higher rates of heart attacks orstrokes.
Novo had previously said it would decide during the firsthalf of this year whether to submit interim or full trialresults. Waiting for full results would have jeopardised its aimof getting to market in 2016.
Tresiba, an ultra-long-acting form of insulin that is alsoknown as degludec, is seen as a crucial future growth driver forthe world's top insulin maker as it battles to maintain marketshare in the face of stiff competition.
Industry analysts forecast it will generate annual sales of$2.2 billion by 2020, according to consensus estimates compiledby Thomson Reuters Cortellis.
Novo noted that results from an interim trial analysiscarried a higher level of uncertainty than final study data."Accordingly, the relative risk estimate that has been derivedfrom the interim analysis is thus only an indication of thefinal trial results," it said in a statement.
Following the submission, the FDA is expected to communicateeither its acceptance of the filing or issue a so-calledincomplete response letter within a month. (Reporting by Ben Hirschler; Editing by David Evans and DavidHolmes)
(Reuters) - Denmark's Novo Nordisk saidon Thursday it had decided to submit interim analysis data froma clinical trial of its crucial new insulin drug Tresiba to U.S.regulators within the next month.
The decision is likely to be a relief to investors, since adecision not to file on Tresiba and the related drug Ryzodegwould have further delayed a launch in the world's biggestmarket.
The U.S. Food and Drugs Administration (FDA) asked Novo toconduct the dedicated cardiovascular risk trial, known asDEVOTE, after refusing to approve Tresiba in 2013 because ofworries it might be linked to higher rates of heart attacks orstrokes.
Novo had previously said it would decide during the firsthalf of this year whether to submit interim or full trialresults. Waiting for full results would have jeopardised its aimof getting to market in 2016.
Tresiba, an ultra-long-acting form of insulin that is alsoknown as degludec, is seen as a crucial future growth driver forthe world's top insulin maker as it battles to maintain marketshare in the face of stiff competition.
Industry analysts forecast it will generate annual sales of$2.2 billion by 2020, according to consensus estimates compiledby Thomson Reuters Cortellis.
Novo noted that results from an interim trial analysiscarried a higher level of uncertainty than final study data."Accordingly, the relative risk estimate that has been derivedfrom the interim analysis is thus only an indication of thefinal trial results," it said in a statement.
Following the submission, the FDA is expected to communicateeither its acceptance of the filing or issue a so-calledincomplete response letter within a month. (Reporting by Ben Hirschler; Editing by David Evans and DavidHolmes)
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