FDA Rejects New Diabetes Drug for Now
It has been recently revealed that the drug for diabetes which was under trial by the FDA is not passed for authenticity for now. They are of the view that there is need for more research and data on the drug, before they can approve it. The name of the drug is dapagliflozin and the FDA is of the view that there is need to prove its worth according to safety, before it can be approved. It has been made by the firms Bristol-Myers Squibb and AstraZeneca.
The firms are of the view they have faith in their product and are going to follow the government procedure for proving the worth of the drug, and showing that it is safe as well.
There have been many other firms making similar drugs, which are under scrutiny, for their safety. For now, the US, Food and Drug Administration is of the view that they cannot give an OK to the drug. They need to know more about the drug, its uses and side effects, before they can authenticate it for use to the public.
The firms who have produced the drug are of the view that they “will work closely with the FDA to determine the appropriate next steps for the dapagliflozin application,” and that they are currently in discussions with health authorities in Europe and elsewhere, “as part of the application procedures”.
It means another few procedures of research and development and experiments that shall prove to the FDA that the drug is safe and effective, are required. This shall help the drug pass its tests and come out for the use of common people, in the time to come, if it is able to prove its worth.
Prospects for a new diabetes drug – known as dapagliflozin – have been dwindling since advisors to America’s Food and Drug Administration (FDA) last year voted against recommending the medicine be approved.
Therefore, it came as little surprise to the City yesterday when the FDA rebuffed the drug, saying it would need further clinical data before giving the once-a-day medicine the green light.
Nonetheless, Astra sank 41½p to £30.70 as the news compounded recent pipeline setbacks for the drug maker, which last month said it would take a $381.5m (£247m) charge after two potential medicines disappointed in trials.
Astra is developing dapagliflozin with America’s Bristol-Myers Squibb and the pair said they remained committed to the drug, but analysts expectations have been falling.
However, Savvas Neophytou of Panmure Gordon, who has a “buy” on Astra, still had hopes for the drugs. “If the product was dead in the water, as the market largely expects, the agency would have rejected the application outright,” he said.
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