Biogen's newly approved Alzheimer's drug Aduhelm generated $2 million in revenue for Biogen in the first few weeks following its approval, the drugmaker said in its second quarter earnings report released July 22.
The company boosted its revenue guidance for the year, now expecting total sales of $10.65 billion to $10.85 billion this year, up from its previous estimate of $10.45 billion to 10.75 billion.
Aduhelm, which was approved June 7, is expected to generate billions in revenue for Biogen, CNBC reported.
The FDA's decision to approve the drug has faced a slew of controversy, with physicians resigning from the FDA's advisory committee and health systems saying they won't administer the drug to patients. FDACommissioner Janet Woodcock, MD, has requested HHS conduct an independent review of the correspondence between the FDA and Biogen during Aduhelm's approval process.
Biogen's head of research and development, Alfred Sandrock, MD, PhD, penned an open letter July 22 defending the drug's approval and saying it has been subject to "extensive misinformation and misunderstanding."
"We welcome a formal review into the interactions between the FDA and Biogen on the path to the approval of aducanumab. A better understanding of the facts is good for everyone involved to assure confidence in both the therapy and the process by which it was approved, as we prioritize the issues that affect patients," he wrote.