Biogen defends Alzheimer's drug approval, reports $2 million in early sales

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The decision by the U.S. Food and Drug Administration to approve the drug, Aduhelm, despite its panel of outside experts recommending against it has drawn criticism from doctors and hospitals, with some saying they will not prescribe the treatment or have prescribed it very slowly.

The company’s shares rose 1.3% to $327.44 in early trading, also boosted by Biogen (NASDAQ:BIIB) raising its full-year revenue expectations.

“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,” Alfred Sandrock, head of research and development, said in an open letter addressed to the Alzheimer’s disease community.

The company recorded $2 million in sales of the drug in the quarter, compared to analysts’ average estimate of $3.23 million, according to IBES data from Refinitiv.

It expects modest revenue from Aduhelm this year, and expects it to ramp up thereafter.

Biogen now expects total sales of $10.65 billion to $10.85 billion this year, from its prior estimates of $10.45 billion to $10.75 billion. The company earned $448.5 million, or $2.99 per share, in the second quarter ended June 30, down from $1.54 billion, or $9.59 per share, a year earlier.