July 22 (Reuters) – Biogen Inc on Thursday mounted a defense of its interactions with U.S. regulators that led to a controversial approval of its new Alzheimer’s treatment, as the company seeks to quell concerns about the drug’s effectiveness.
The company recorded nearly $2 million in sales of the drug, which was approved on June 7, in the second quarter, while analysts on average had estimated $3.23 million, according to IBES data from Refinitiv.
The decision by the U.S. Food and Drug Administration to approve Aduhelm despite its panel of outside experts recommending against it has drawn criticism, with the agency asking federal investigators to review the process.
“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 at Biogen, said in an open letter to the Alzheimer’s disease community.
The company’s comments about the drug’s approval make it clear that there is “little chance of the controversy abating in the near term,” said Wedbush analyst Laura Chico.
Aduhelm’s $56,000 per year price tag has also spurred lawmakers to launch a probe, with insurers waiting for clarity before starting coverage.
The drugmaker expects modest revenue from Aduhelm this year and to ramp up thereafter, adding it was seeing “strong indications of very high initial patient interest as well as increased referrals.”
Biogen now expects total sales of $10.65 billion to $10.85 billion this year, compared with its prior estimate of $10.45 billion to $10.75 billion.
The company’s shares gained 1.1% to $326.50 in early trading.
Reporting by Manas Mishra in Bengaluru; Editing by Sriraj Kalluvila
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