(Reuters) – Biogen said on Tuesday its Chief Executive Michel Vounatsos will step down, with the drugmaker adding it would scale down its sales infrastructure for the controversial Alzheimer’s drug Aduhelm.
Below are the events to the drug’s long-winding, controversial approval last June and developments since:
2007: University of Zurich spin-off Neurimmune Therapeutics licensed exclusive rights of aducanumab to Biogen. (https://bit.ly/3g3MlFm)
March, 2014: Eisai Co Ltd agrees to collaborate with Biogen to develop treatments for Alzheimer’s disease, including an option for the Tokyo-based company to jointly develop and commercialize aducanumab. (https://bit.ly/3JgMGRu)
March, 2015: The first sign aducanamab could work is seen when Biogen released interim data from a small study that showed reduced brain-destroying amyloid plaque and slowed clinical decline in patients with mild disease. (https://reut.rs/3g1HHHM)
July, 2015: Biogen’s trial of 6 milligrams of aducanumab, a dose it hoped would be effective without producing the brain swelling seen in higher doses, failed to significantly slow mental decline. (https://reut.rs/37xO1Gx)
September, 2015: Biogen started to test aducanumab in people with early Alzheimer’s disease in its two global, late-stage studies known as ENGAGE and EMERGE. (https://bwnews.pr/34IyKhd)
March, 2019: Aducanamab found unlikely to be successful by an independent committee monitoring its large trials. Biogen ended the studies and lost $18 billion in market value. (https://reut.rs/3cax98b)
October, 2019: A new analysis of two discontinued studies showed the drug slowed progression of Alzheimer’s and Biogen revived plans to seek U.S. approval. (https://reut.rs/3pgD8gZ)
July, 2020: Biogen completed the submission of a biologics license application to the U.S. FDA for the approval of aducanumab. (https://bit.ly/3E1aHLu)
November, 2020: FDA staff said Biogen showed “exceptionally persuasive” evidence that aducanumab is effective in documents released ahead of a meeting of outside experts who considered whether to recommend approval. (https://reut.rs/3ujL4Cj)
November, 2020: The panel of outside advisers to the FDA disagreed with the agency’s staff and voted that aducanumab had not been proven to slow progression of the disease. (https://reut.rs/3rd58nN)
June, 2021: The U.S. health regulator approved aducanumab, branded as Aduhelm, saying that the reduction in amyloid plaque is likely to slow the rate of cognitive decline in Alzheimer’s patients. The agency turned to an accelerated pathway designed to bring promising drugs to market quickly to enable the move.
June, 2021: Biogen priced the drug at $56,000 per year for an average weight person.
June, 2021: FDA released documents that revealed disagreements within the agency over the decision to approve the drug. At least three members from a panel of outside advisers to the regulator resigned in protest.
July, 2021: FDA changed its initial broad decision on Aduhelm’s use to restrict the drug to patients with mild cognitive impairment or mild dementia stage of Alzheimer’s. The agency called for an independent federal probe into its interactions with Biogen.
July, 2021: Biogen recorded second-quarter sales of about $2 million from Aduhelm. The company said a “big chunk” of that revenue reflected inventory buildup and had not yet been administered to patients.
August-September, 2021: U.S. lawmakers launched an investigation on the accelerated approval of the drug and requested documents from the FDA related to the decision.
October, 2021: Aduhelm brought in much lower-than-expected sales of $300,000 in its first full quarter as doctors held back on using the drug.
December, 2021: The European Medicines Agency rejected Aduhelm, saying the link between the drug’s reduction of amyloid beta and a clinical improvement in the disease had not been established.
December, 2021: The company cut the U.S. price of the drug by about half to $28,200.
January, 2022: U.S. Medicare announced plans to cover Aduhelm only for patients enrolled in a clinical trial, limiting access to the drug.
February, 2022: The Federal Trade Commission and the Securities and Exchange Commission began investigating Biogen over the drug.
March, 2022: Tokyo-based partner Eisai cuts its role to a royalty agreement, giving up right to share profit from Aduhelm.
March, 2022: Biogen published data from its long-term studies in the lesser-known Journal of Prevention of Alzheimer’s Disease.
April, 2022: The Centers for Medicare and Medicaid Services issued its final coverage policy for Aduhelm.
April, 2022: Biogen said it will withdraw the marketing application for the drug in Europe after failing to convince the European regulator of the treatment’s benefits.
May, 2022: Biogen said Chief Executive Officer Michel Vounatsos will step down after a successor is appointed and that it plans to “substantially” eliminate commercial infrastructure related to Aduhelm.
(Reporting by Bhanvi Satija and Leroy Leo in Bengaluru; Editing by Bill Berkrot, Peter Henderson, Sriraj Kalluvila and Krishna Chandra Eluri)