FDA restricts use of Biogen’s hit Alzheimer’s drug


The biotech world has been more volatile than ever following Biogen’s (NASDAQ: BIIB) Alzheimer’s drug winning approval back in June. Ever since the news broke, shares of Biogen surged, especially since many investors were wondering whether or not the drug would get approved in the first place. However, the Food and Drug Administration (FDA) has just announced that it will be narrowing the suggested use cases for the new drug, somewhat dialing back on what was previously a strong recommendation.

The FDA now recommends that Biogen’s Alzheimer’s drug, called Aducanumab, be used only on patients with early-stage disease symptoms. That’s different from what the FDA originally approved the drug for, which was for patients with differing severities of Alzheimer’s, but closer in line with what the original phase 3 Biogen trials were focused on.

Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials,” said the updated recommendation label. “There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.”

Many doctors were skeptical about whether Aducanumab would be approved in the first place, given some questionable results clinical results leading up to the initial FDA decision. The drug works by helping clear the brain of a sticky protein called amyloid, which is believed to play a role in the progression of Alzheimer’s. These proteins end up slowing down and inhibiting the neurons in the brain. Up until this point, almost no treatment had any success in inhibiting these proteins from developing.

Looking at the clinical results themselves, it seemed that the drug had the best efficacy on patients whose Alzhiemer’s diagnoses were relatively minor in severity. Additionally, even those results weren’t as convincing as some had hoped. Despite that, however, the FDA ended up approving the drug.

Since then, investors have paid close attention to other potential Alzheimer-plays within the biotech sector. Some of these smaller Alzheimer-stocks include INmune Bio (NASDAQ: INBM), Cassava Sciences (NASDAQ: SAVA), and Annovis Bio (NASDAQ: ANVS), all of which have been recommended recently by analysts on Wall Street.

Shares of Biogen were up by around 3.9% on the news, not really affected by the restricted label for Aducanumab. Back when the drug was approved in early June, Biogen’s market cap surged by more than 50% as traders jumped on the good news. Since then, shares have fallen by around 20% or so but are starting to making a comeback once again.


Biogen Company Profile

Biogen and Idec merged in 2003, combining forces to market Biogen’s multiple sclerosis drug Avonex and Idec’s cancer drug Rituxan. Today, Rituxan and next-generation antibody Gazyva are marketed via a collaboration with Roche. Biogen also markets novel MS drugs Tysabri and Tecfidera. In Japan, Biogen’s MS portfolio is co-promoted by Eisai. Hemophilia therapies Eloctate and Alprolix (partnered with SOBI) were spun off as part of Bioverativ in 2017. Biogen has several drug candidates in phase 3 trials in neurology and neurodegenerative diseases and has launched Spinraza with partner Ionis. – Warrior Trading News