Lilly's Donanemab faces unexpected advisory committee review, Amylyx's ALS drug fails in Phase III study, and Biogen grapples with logistical challenges in ending Aduhelm trial. These setbacks underscore the complexities of developing neurosciences drugs.
Lilly's Donanemab Faces Unexpected Advisory Committee Review
( Credit to: Pink )
Lilly's Alzheimer's drug, Donanemab, has generated anticipation for its potential approval. However, the recent announcement that the drug will undergo an advisory committee review has come as a surprise.
This decision is believed to be linked to the translation of the drug's complex trial design into appropriate labeling recommendations. Despite this setback, experts remain optimistic that the FDA is not considering an outright rejection of the drug, as it had previously been viewed as a likely candidate for approval.
Amylyx's ALS Drug Fails in Phase III Study
In another blow to the field of neurosciences, Amylyx has revealed disappointing results from a Phase III study of its ALS drug, Relyvrio. The drug failed to meet expectations, leaving the company with the decision of whether to voluntarily withdraw it from the market.
During the FDA review process, Amylyx had committed to removing Relyvrio from the market if the study did not yield positive results. The company now plans to engage with regulators and the ALS community to discuss the implications of the trial outcome and make informed decisions moving forward.
Biogen Faces Logistical Challenges in Ending Aduhelm Trial
Biogen, the manufacturer of Aduhelm, an Alzheimer's drug that gained controversial FDA approval, now faces the challenge of ending its ENVISION confirmatory study.
This multinational trial involves over 200 sites and approximately 1,000 patients, making the logistical complexities of shutting it down significant for the company.
In addition to the logistical hurdles, Biogen is also under pressure to publish the data collected from the unfinished study, as well as data from other aducanumab trials.
Conclusion: Regulatory Challenges in Neurosciences
The recent setbacks in the field of neurosciences highlight the regulatory challenges faced by pharmaceutical companies developing drugs for neurological disorders.
These unexpected developments, such as the advisory committee review for Lilly's Donanemab, the failure of Amylyx's Relyvrio in a Phase III study, and the logistical hurdles faced by Biogen in ending the ENVISION trial for Aduhelm, emphasize the complexities involved in bringing neurosciences drugs to market.
These setbacks serve as reminders of the need for regulatory flexibility and thorough evaluation to ensure the safety and efficacy of these treatments.