Biogen Inc.’s Alzheimer’s drug gets closer to a U.S. Food and Drug Administration approval as FDA staff gives positive clinical reviews.
Right after the positive clinical review posted by the U.S. Food and Drug Administration on Wednesday, Biogen Inc.’s stocks leaped a staggering 44%, adding approximately $17 billion to Biogen’s market value. Since February, Biogen’s highest point is closing its value at $55 billion from the former $38 billion.
Biogen in August said that they have applied for the FDA approval of the experimental drug, aducanumab. It was developed by Biogen Inc. together with a Japan-based partner, Eisai Co.
Studies for aducanumab were stopped in March 2019 due to the drug potentially not working. Further research was started in October of the same year after results from a trial resulted in success. Additionally, several controversies emerged due to a failed Phase 3 testing but later succeeded in Emerge, another Phase 3 testing.
“Based on the considerations above, the applicant has provided substantial evidence of effectiveness to support approval.”According to the clinical review posted by the FDA
The FDA also stated that Biogen’s results from its late-stage trial are “highly persuasive.”
“[It is] capable of providing the primary contribution to a demonstration of substantial evidence of the effectiveness of aducanumab…”FDA
According to Biogen, the trials showed that the experimental drug helped slow down Alzheimer’s patients’ memory loss and other vital functions, including language. Aducanumab was also found to target beta-amyloid, a protein that can build up in the brain and later cause Alzheimer’s disease.
“[Aducanumab has] an acceptable safety profile that would support use in individuals with Alzheimer’s disease.”FDA
The Massachusetts-based drug developer presented trial results in December of 2019. One trial slowed down Alzheimer’s progression, while the other found no significant effects. Further, experts put the results into the test because some participants couldn’t complete the trials.
According to Wall Street analysts, they were surprised by the positive review from the FDA.
“Simply put: we are struck by the aducanumab FDA briefing book and how consistent the agency’s view of the data are with that of Biogen.”Stifel Nicolaus & Co. analysts
Alzheimer’s disease, a progressive neurodegenerative disorder, destroys memory and thinking skills and affects approximately 5.8 million Americans. Moreover, it is the 6th leading cause of death in the United States.
Experts from various firms are expected to meet Friday to push for the drug’s FDA approval.