SUMMARY: The FDA is coming under intense pressure to approve Biogen’s Alzheimer’s drug, but Aaron S. Kesselheim, a professor of medicine at Harvard Medical School via the Washington Post, says “the worst thing for people with Alzheimer’s would be to put out a product that doesn’t work.” For Biogen, the stakes are high as approval is likely to earn tens of millions, of to billions, in profits but is hope a reason to approve a drug over science?
SUMMARY: Endpoints and STAT news are reporting that Biogen is coming under intense scrutiny when it comes to their failed drug aducanumab. According to the Endpoints report “On Monday Baird’s Brian Skorney — a prominent Wall Street analyst — kicked off the week with a scathing assessment of the data Biogen has presented to date and a declaration that barring a deus ex machina — an unlikely savior — there’s no way the FDA would approve a drug on this data, outlining a variety of issues that would freeze any other drug in its track”.
WHAT ARE PEOPLE SAYING: STAT news article “I used to work on Biogen’s Alzheimer’s drug. Is the company spinning bad data?” is generating quite a debate. Some people support Biogen’s submission of the drug, while others are skeptical. This could be settled very quickly if Biogen would allow people outside the company to review ALL the data.
KEY TAKEAWAY: “We still believe that amyloid beta hypothesis is potentially the right approach for the treatment of Alzheimer’s disease,” an Eisai spokesman told Reuters. What made Wall Street and everyone else, Eli Lilly, AstraZeneca, Merck, and Roche — have reported out decisive late-stage failures over the last year that all point to one conclusion: Targeting amyloid-beta alone in symptomatic patients may hit your biomarkers on effect, but it doesn’t delay the ruthless march of the disease.
- Eisai and Biogen posted promising data for BAN2401 that lifted its stock and had the pharma trade publications talking breakthrough.
- But there is a lot of controversy swirling around the study.
- It seems that Biogen may have moved the goal posts to gain more favorable data endpoints.
- It’s not about patients, it’s about the stock price and getting investors on board.
KEY TAKEAWAY: Spending $40 million on a DTC campaign to increase awareness of a drug that people are demolishing on social media is a waste of money. Surely DTC marketers can do better than this.