Biotech large Biogen stated Thursday that it introduced in about $1.6 million in gross sales from its controversial Alzheimer’s drug final month after it was authorized by the Meals and Drug Administration earlier in June.
The drug, which is marketed as Aduhelm, is the primary new therapy for Alzheimer’s in about 18 years and the primary that docs are hoping is not going to simply reduce signs however goal the underlying illness.
The corporate stated in its second-quarter earnings report that the drug, which was authorized by the FDA on June 7, did $1.6 million in gross sales earlier than the top of the quarter, which was June 30.
The corporate’s income from Aduhelm is modest now, however the drug has only recently been rolled out. The corporate reported whole income of just about $2.8 billion for the quarter, down 25 p.c from a yr earlier.
The corporate stated it expects Aduhelm to proceed to contribute modest income this yr, with a ramp-up thereafter.
Biogen has slapped a $56,000-per-year price ticket on Aduhelm, outraging some Alzheimer’s advocates and even elevating questions amongst Wall Road analysts.
The drug’s approval by the FDA introduced hope to the greater than 6 million People residing with Alzheimer’s — though some docs objected to the approval, saying there’s not sufficient proof to point out it’s really efficient.
Three scientists on a panel advising the FDA reportedly resigned after the drug’s approval.
“This is perhaps the worst approval determination that the FDA has made that I can keep in mind,” Dr. Aaron Kesselheim stated, in line with the New York Occasions.
Regardless of considerations, final month a Rhode Island man grew to become the primary affected person to get a transfusion of the drug.
And questions have since been raised over whether or not the corporate performed a job in influencing inside FDA deliberations.
Earlier this month, the FDA’s appearing commissioner Janet Woodcock referred to as on the unbiased Workplace of the Inspector Basic to analyze whether or not executives from Biogen met with FDA workers outdoors of formal correspondence.
“There proceed to be considerations raised … concerning contacts between representatives from Biogen and FDA through the overview course of, together with some which will have occurred outdoors of the formal correspondence course of,” Woodcock wrote in a letter posted Friday to appearing Inspector Basic Christi Grimm.
“To the extent these considerations may undermine the general public’s confidence in FDA’s determination, I imagine it’s essential that the occasions at concern be reviewed by an unbiased physique such because the Workplace of Inspector Basic with a purpose to decide whether or not any interactions that occurred between Biogen and FDA overview workers had been inconsistent with FDA insurance policies and procedures.”