The Minotaur is one of the most terrifying monsters to emerge from Greek mythology. Born out of a curse levied by an angry Poseidon, the unnerving creature had a human body and a bull’s head, complete with massive horns that were not to be trifled with.
As if a half-human, half-bull isn’t enough to haunt your dreams, the Minotaur also had an insatiable desire to consume human flesh.
When the Minotaur was born, King Minos (whose wife had given birth to the beast after sleeping with a bull — don’t ask) didn’t know what to do with his new (step?) son. In order to contain the flesh-hungry Minotaur, the king had a famous craftsman build a labyrinth to entrap it forever.
The labyrinth was built to be inescapable; a literal death trap where anyone who entered had to navigate a complex terrain stained with the blood of those who dared enter before them, only to eventually be torn to shreds and devoured by the Minotaur.
Referring to the complex FDA drug approval process as a labyrinth (or more commonly, a maze) is not a new analogy. The path from IND to approval is not for the faint of heart and is typically wrought with costly failure.
Perhaps for no other indication is that fact quite as harsh as it is with Alzheimer’s disease, where the common calculation is that 99 percent of drugs developed ultimately fail. It has been 18 years since the FDA approved a new Alzheimer’s treatment and to date, no disease-modifying drug has ever successfully navigated the regulatory maze.
But this June, Biogen may make history. The FDA is scheduled to finally render a verdict on aducanumab, the biotech’s controversial beta-amyloid targeting antibody.
To say the least, aducanumab’s path to approval has been full of unexpected twists, and on more than one occasion, it appeared as though the drug had taken a turn towards certain death.
Now, the clock is ticking down and everything is on the table for debate — Biogen’s trial design, its data, and even the company’s relationship with the FDA — and industry onlookers are divided. There are Biogen critics and Biogen bulls.
Whatever fate awaits aducanumab, the FDA’s decision will have ramifications beyond Biogen. The approval (or rejection) will impact patients, the industry’s Alzheimer’s pipeline and even the science behind Alzheimer’s treatments.
Pharma Manufacturing’s March issue is always devoted to a “state of the industry” themed report that includes a cover story about whatever topic is currently on the lips of pharma.
Last year, we tackled oncology. The oncology sector is filled with phrases like “dazzling speed” “fever pitch” and “frenzy” — none of which really apply to the Alzheimer’s discussion. And yet, for the estimated 6 million Americans suffering from the brain-wasting disease with little treatment options, hope of relief cannot come fast enough.
One thing is certain: A legendary payoff is inevitable for the company that manages to navigate the labyrinth and finally cut through the bull.
Read this month's cover story, The Alzheimer's approval maze