The US laboratory Biogen on Thursday defended its controversial new drug against Alzheimer's which it sold for 1.6 million dollars in the second quarter, acknowledging that its launch was
"slower"
than expected.
Read also: Failure in Alzheimer's disease forces Biogen to reinvent itself
The American Medicines Agency (FDA) gave the green light at the beginning of June, via an accelerated procedure, to the sale of this product called Aduhelm, the first treatment approved against Alzheimer's disease since 2003. But this decision made vague in the scientific and medical communities, the FDA having gone against the opinion of a committee of experts which had ruled that the treatment had not sufficiently demonstrated its effectiveness in clinical trials. Critics have grown in importance as Biogen sells the treatment for $ 56,000 per year.
Under pressure, the FDA announced in early July that it had changed its recommendations for the use of the drug, restricting its use to people with moderate cases of the disease only.
"Aduhelm's approval is the subject of a lot of misinformation and misunderstanding,"
said the company's head of research, Alfred Sandrock, in an open letter. The green light from the FDA
"is based on careful analysis of the data,"
he said.
"We welcome the launch of a formal review of interactions between the FDA and Biogen during the
drug
approval process,"
he also said, saying that a
"better understanding of the facts"
will build confidence in the product and in the process.
"I want to be clear that Biogen supports the integrity of the review process
,
"
also said the company's CEO, Michel Vounatsos, during a conference call with analysts Thursday.
"Very high initial interest of patients"
“Overall, (the drug's launch) is slower than we anticipated,”
he noted. The company continues to forecast
“modest”
revenues
for the Aduhelm in 2021, but these
“should
ramp
up afterwards”
.
"We have seen strong indications of a very high initial interest from patients"
for the product, assured Michel Vounatsos.
But some medical institutions have already indicated that they will not administer it while others have yet to make their decision. The repayment terms are also still uncertain. The group has also indicated that it is in the process of discussing Aduhelm with the regulatory authorities for drugs in Europe, Japan and other markets.