Biogen plans Alzheimer’s drug approval after initial research failure
pharmafile | October 25, 2019 | News story | Medical Communications |
Biogen is planning to seek approval for its experimental drug aducanumab, that could potentially be first to treat Alzheimer’s and be the first drug to be approved since 2003.
The company abandoned the treatment earlier this year after results showed no benefit, however a new analysis of a larger data set had a notable impact on Alzheimer’s patients when taken at a higher dose.
Initially, researchers at Biogen were concerned about a potential side effect – brain swelling- and so limited the dosage of the drug. Later, however patients were able to receive higher doses of the medication with little adverse effect.
The company stated that patients who received the higher dose “experienced significant benefits on measures of cognition and function such as memory, orientation, and language.” The patients were better able to complete day to day tasks such as cleaning, shopping, managing personal finances and travelling independently.
Biogen CEO Michel Vounatsos said that it was “reasonably confident” the US FDA will approve the Alzheimer’s drug and worked in full transparency with the regulator.
He added: “The evidence came over time. We collected a tremendous and complex set of data, including biomarkers and imaging. This was a thorough engagement and as CEO I’m reasonably confident this will lead to market approval one day.”
The news meant that Biogen shares soared by 26% after the drug manufacturer announced it was seeking approval for its previously failed drug. Biogen’s research failure followed a series of other failures from many different drug companies, most of which targeted a protein in the brain called beta amyloid – a theory which has now in part been debunked due to insufficient efficacy.
At the time of the drug’s failure, Biogen lost billions of dollars in market value and the scientific and pharmaceutical community saw the announcement as a setback, especially since the company had already spent billions to research and develop possible treatment – with nearly nothing to show for it.
Al Sandrock, Biogen’s Head of Research and Development and Chief Medical Officer, remarked: “In retrospect, the results of the futility analysis was incorrect.
“That’s because it was from a smaller dataset that looked at patients with less exposure to high dose aducanumab.”
Sandrock went onto say that the futility analysis happened too soon and it had looked on data based on last December when the trials were actually stopped in March. Biogen had actually run two studies with one being positive in its own right on the higher dose.
There are currently no drugs approved that can reverse the mental decline of Alzheimer’s and current FDA approved treatments are aimed at helping symptoms and not improving or slowing the onset of the disease itself.
Nik Kiran
