The pharmaceutical company, Biogen, will be looking for the go ahead from the United States Food and Drug Administration (FDA) to continue the development of the Alzheimer’s treatment, aducanumab.
Phase 3 clinical tests of the treatment were stopped earlier this year after the outcome of a futility analysis revealed that the main objectives weren’t likely to be achieved upon completion.
Yesterday, Biogen mentioned a new analysis that displayed a noteworthy decrease in clinical decline. Findings from other patients in a separate study backed up these results. Patients who were given aducanumab showed substantial improvements in cognitive ability and functionality. According to Biogen, the patients made progress regarding the performance of their memory, their situational awareness, and their language skills.
“I really hope these new analyses pan out,” said the Director of the Alzheimer’s Prevention Clinic at Weill Cornell Medicine in New York, Dr. Richard Isaacson. “I’m not surprised that a reanalysis of the data showed something positive,” he says. “I do believe that there are going to be probably continued regulatory hurdles.”
Isaacson noted that the treatment could also fetch a fair price.
“The complicated aspect here is I would not be surprised if additional analyses, with larger (numbers), with higher doses, do show signals in either the overall population or subgroup analysis, but is that going to be enough for the FDA to approve this from a regulatory perspective? Would payers reimburse it? I don’t know, but I hope so,” said Isaacson.
Biogen is expected to file an application with the FDA in the beginning of next year and will consult with officials in Europe and Japan regarding regulations. The treatment will be available to certain patients who were involved in the last Phase 3 studies.
“This is the result of groundbreaking research and is a testament to Biogen’s steadfast determination to follow the science and do the right thing for patients,” said Michel Vounatsos, Chief Executive Officer of Biogen. “We are hopeful about the prospect of offering patients the first therapy to reduce the clinical decline of Alzheimer’s disease and the potential implication of these results for similar approaches targeting amyloid beta”.
The collection of beta-amyloid is thought to be main factor responsible for Alzheimer’s disease – the sixth biggest cause of death in the U.S.
Chief Science Officer at the Alzheimer’s Association, Maria Carrillo, says, “The Alzheimer’s Association is encouraged to learn that Biogen will pursue regulatory approval from the FDA for the investigational drug aducanumab based on Phase 3 clinical trial results from the EMERGE and ENGAGE studies, and other related data, after finding a reduction of cognitive and functional decline in people taking the high dose”.