Despite a flurry of uncertainty surrounding Biogen’s Alzheimer's hopeful aducanumab, the company has forged ahead with its launch preparations ahead of a pending FDA decision. Now, its Swiss manufacturing facility is a step closer to eventually churning out doses—should the drug score an approval.
Switzerland’s medicines surveillance authority, the Swiss Agency for Therapeutic Products (Swissmedic), issued Biogen's Solothurn manufacturing facility a Good Manufacturing Practice (GMP) license, the company said.
The certification is “an important step in the readiness of the site, which enables the future submissions of product files to regulatory authorities,” Biogen said. Notably, the Swiss facility could eventually manufacture doses of aducanumab if approved, expanding on Biogen’s existing capacity in Research Triangle Park, North Carolina.
More than 500 employees work at the site, which the company says could be expanded in the future. Biogen in 2015 said it would invest $1.2 billion to build the next-gen manufacturing facility.
The Swiss facility will also have the ability to manufacture doses of Biogen’s other investigational Alzheimer’s treatment, lecanemab (BAN2401), which is currently in phase 3 testing.
Biogen is ready to distribute aducanumab to more than 600 clinical sites in the U.S. if given the FDA’s go-ahead in the coming weeks and expects strong demand out the gate, CEO Michel Vounatsos told analysts on a call last month.
But the jury is still out on whether aducanumab is actually a breakthrough drug as it faces an uncertain future. Some analysts have predicted it stands less than a coin flip’s chance of a clean FDA approval. Payers could cite questions around the data to restrict coverage, as well.
Meanwhile, a U.S. cost watchdog has already tagged the drug with a low recommended price. Given the “insufficient” evidence on its benefits, the drug should cost as low as $2,500 for a year of treatment to be considered cost-effective, the Institute for Clinical and Economic Review (ICER) said in a draft report published earlier this month.
Many patients and their families, though, are hoping for an approval. The Alzheimer's Association is among those pushing for an FDA nod.