Biogen to seek FDA approval for Alzheimer's drug which it claims can slowdown disease
Bringing cheers to millions of people living with Alzheimer's around the world, the US drug company, Biogen, has announced that their drug holds promise in slowing down the disease. Driven by the results, the company along with Tokyo's Eisai will now seek approval from the US Food and Drug Administration (FDA).
The news comes after Biogen pulled the plug on the drug, aducanumab, in March 2019. The initial analysis of the phase 3 trials proved that the drug was ineffective. Previously, all the drugs tested for the disease have failed.
However, the company now claims that the fresh analysis, which includes additional data, reveals a positive picture: patients showed improvements in memory, orientation, and language. Their results also showed that drug has helped patients lead a better life, from taking care of personal finances and performing household chores such as cleaning, shopping, and doing laundry to being able to independently travel out of the home.
If approved, this could very well be the first successful drug for the disease. "The situation is highly unusual and it will be up to the FDA to decide whether to approve the drug based on a single positive trial", Al Sandrock, Biogen’s head of research and development and chief medical officer, told STAT.
Of the two trials the company ran, one failed. In the first trial named Emerge, they compared results between high and low doses of the drug: patients who were put on a high dose of the drug had a 23 percent reduction in their rate of decline compared to those on placebo. And patients who were put on low dose showed a decline of 11 percent lower than the placebo group. The second trial named Engage failed: the company saw a decrease of only 2 percent in patients on high dose.
According to Biogen, the patients in Emerge received higher doses due to changes made late in the studies. The contradictory results have invited some degree of skepticism. For instance, STAT reported that Umer Raffat, an analyst at the investment bank Evercore/ISI, was confused by the results. In his note, he wrote that given the one positive result, it is “not inconceivable that FDA is open to this filing.” However, whether an FDA approval would translate into commercial success is “a whole different debate."
But Biogen will be conducting more studies. This time, they will include all patients from the former study in the test group, meaning that every patient will be treated with the drug, Samantha Budd Haeberlein, Biogen’s lead Alzheimer’s scientist, told STAT. The team will work to get the study up and running for patients as soon as possible.