There is reasonable confidence with Biogen CEO Michel Vounatsos about getting the approval for the drugmaker’s experimental Alzheimer’s drug from the United States Food and Drug Administration.
“We worked in full transparency with the regulator,” Vounatsos said in a television interview while also emphasizing that all of the data about the drug that the company possessed has been given to the FDA.
“The evidence came over time. We collected a tremendous and complex set of data, including biomarkers and imaging,” he said. “This was a thorough engagement, and as CEO I’m reasonably confident this will lead to market approval one day.”
Following the sudden and apparently shocking announcement by the drug maker that it was seeking to get approval from the FDA for its once failed Alzheimer’s drug called aducanumab, there was huge gain of 26 per cent in the shares of Biogen on Tuesday.
The company had earlier in March this year announced its decision to stop the late-stage trials for its drug after they were opined to be largely ineffective in the future to control the disease by an independent audit.
At the time, the shares of the company had taken a huge hit resulting in billions of dollars being wiped out of its market value. The company had spent billions to research and develop possible treatments and the announcement by the company had been viewed as a setback for the entire pharma industry according to the scientific community. There was also disappointment among patients and families living with the disease and who had hoped for a cure to this seemingly incurable disease.
The memory and mind of people who have Alzheimer’s disease can get deteriorated to the extent that they stop functioning and the patients eventually die. In the US, Alzheimer’s causes the sixth most deaths and according to the data of the Alzheimer’s Association, more than 5.8 million Americans are currently suffering from the disease.
Currently, there are no medicines that can cure or even stop the degeneration of the mind and the memory because of Alzheimer’s and bringing them back to their natural state. Those drugs for the disease that have been approved by the FDA are able to treat the symptoms of Alzheimer’s but none have the ability to regenerate the loss of the mind and memory.
A compound in the brain known as beta-amyloid is targeted by the experimental drug of Biogen. Beta-amyloid is believed to have a key role in development and progression of the devastating disease as it is bale to erode synapses between nerve cells.
A new analysis of a larger dataset showed that aducanumab “reduced clinical decline in patients with early Alzheimer’s disease”, Biogen said on Tuesday, and added that those patients who had been administered the drug “experienced significant benefits on measures of cognition and function such as memory, orientation, and language.”
There was however some skepticism about the results as many some claimed that the outcome could have been achieved by a fluke.
(Adapted from CNBC.com)