This week, we will delve into the case of Biogen’s Aducanumab and whether an FDA advisory committee non-approval recommendation, definitely predicts a similar decision from the FDA. We also discuss the high-efficacy results from Pfizer & BioNTech’s COVID-19 vaccine and what the future could hold for their vaccine.
FDA Advisory Committee Recommendation for Biogen’s Aducanumab
To approve or not to approve? That is the question the FDA advisory committee (ad com) discussed this week for Biogen’s Alzheimer’s drug, aducanumab. Previously, FDA reviewers found the drug to be safe and effective based on data from one of their large clinical trials. Reviewers endorsed the drug’s effects on the cognition of Alzheimer’s patients. However, a second, nearly identical study did not show a significant benefit. These incongruent results appeared to sway the ad com, a panel of independent experts, who determined that clinical data did not demonstrate enough support to recommend approval. 10 of the 11 ad com members voted that the figures were not enough to show its drug could alter the progression of Alzheimer’s disease. One member voted “uncertain.”
The FDA does not always base final decisions on the recommendations of ad coms. In a study assessing the association between FDA ad com recommendations and agency actions, twenty‐two percent of the FDA’s final actions were discordant with the advisory committee’s recommendations. Of those, 75% resulted in the FDA making more restrictive decisions after favorable committee recommendations, and 25% resulted in the agency making less restrictive decisions after unfavorable committee recommendations. Discordance was associated with lower degrees of ad com consensus and was more likely for agency actions focused on product safety than for novel approvals or supplemental indications. The official determination is expected to come early next year. If approved, aducanumab would become the first FDA-approved drug for alzheimers in nearly twenty years.
Pfizer & BioNtech’s COVID-19 Vaccine
The world is waiting in anticipation for an effective COVID-19 vaccine. This week, Pfizer and BioNTech announced overwhelmingly positive results from their forty-thousand enrolled, phase III clinical trial. After examining 94 cases of COVID-19, a data monitoring committee concluded Pfizer and BioNTech’s vaccine was more than 90% effective in preventing disease. A more comprehensive report concerning efficacy will be announced when Pfizer and BioNTech ask the FDA for an emergency approval. The FDA requested that companies provide a median of at least two months follow-up for their study participants. The two-month requirement is meant to capture rarer, more serious side effects that typically emerge between 40 to 60 days after vaccination. Pfizer expects to have those data as early as next week, after which it would apply for an emergency authorization. Emergency approval is just a first step, full approval of their vaccine will require at least six months of safety data.