Biogen was granted an accelerated approval for a drug called Aduhelm before, however, the manner that drug was approved by the FDA raised serious questions in the scientific community, and to make matters worse the Company’s management screwed up the drug’s launch so badly that the company was forced to abandon the drug and its CEO lost his job.
Biogen lost $100s of billion in market cap and billions of dollars in potential revenue.
That brings us to the latest drug and why it’s so critical for Biogen. The drug called (lecanemab) and commercially known as, Leqembi, has been developed in partnership with a Japanese company called Eisai. The Food and Drug Administration has granted conditional approval for Leqembi.
Dr. Marwan Sabbagh told the WSJ: “We’ve been trying for years, decades, and we need the win”, said Marwan Sabbagh, an Alzheimer’s specialist at the Barrow Neurological Institute in Phoenix and a paid consultant to Biogen and other companies. “Now, we have a small win, a modest win, but it’s a win still.”
Leqembi was approved through the FDA’s accelerated approval pathway, which grants earlier approval to drugs that treat serious conditions and fill an unmet medical need. In December 2022, Congress passed legislation to preserve and strengthen this important regulatory pathway. The company has already completed the confirmatory Phase 3 trial required by the FDA to stay on the market. The trial met its primary endpoint, reducing clinical decline by 27% compared to placebo after 18 months of treatment. The company announced they will submit to the FDA for traditional approval very shortly.
“People living with this fatal disease today do not have time to wait for a miracle drug or cure,” said Joann Pike, Alzheimer’s Association president and chief executive officer. “While we continue efforts to discover new targets and test new treatments, people living with Alzheimer’s deserve the opportunity to discuss and make the choice with their doctor if an FDA-approved treatment that offers benefits is right for them.”
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