![]() If not, you may simply be 'massaging' the data for a (probably false) signal. If using data transformations or discarding data, ensure that there is solid rationale to do so. It would be naïve to expect an appointment, or indeed any major strategic decisions, before Clarity AD reads out."Data dredging" (sometimes called "data fishing") is a real risk which may invalidate any conclusions you draw from your analysis.Įxploratory analyses are used to find subsets of data that confirm (or are more likely to confirm) an a priori hypothesis which may not be generalisable to the whole (statistical) population.Įxploratory analyses are used to generate a hypothesis from a given data set which is tested using the same data set.Įvaluate if your data supports the results of a hypothesis based on previous knowledge and research. On this front Biogen would only say an executive search was proceeding as planned. These are no longer realistic concerns for the group’s chief executive, Michel Vounatsos, who is paying the price for Aduhelm and staying on only until a successor is found. Though Biogen today threw investors the crumb of increased full-year earnings guidance, on the R&D front there was further disappointment: it quietly slipped out the failure and discontinuation of BIIB104, an AMPA agonist, in the phase 2 Tally study of cognitive impairment associated with schizophrenia.īiogen has also discontinued an anti-Tau antibody, BIIB076, in Alzheimer's and the exportin 1 inhibitor BIIB100 for ALS. After Eisai disentangled itself from Aduhelm it reimbursed $46m of costs incurred by Biogen. Biogen took a $71m restructuring charge to cover the effective winding up of a drug that sold $0.1m in the quarter this brought Aduhelm cumulative revenues since it was approved in June 2021 to a measly $5.9m. Second-quarter numbers laid bare the Aduhelm disaster. Tellingly, Biogen has moved to dismantle its commercial infrastructure around Aduhelm should lecanemab somehow succeed this would need to be rebuilt. Still, the likeliest outcome given the track record of amyloid-beta MAbs is that Clarity-AD is a bust. “At this moment we do not have the indication than an adcom will be necessary,” said Ms Singhal. But no one realistically expects the FDA to issue a green light in the absence of confirmatory data.īiogen today confirmed that Clarity AD could serve as the necessary confirmatory trial, and should it be positive the data would be incorporated into an application for full approval by the end of the first quarter. Its filing, handled by Eisai, is on an accelerated basis and has been set a JanuPdufa date. In theory lecanemab could be approved in the absence of any Clarity-AD data. Pdufa date for lecanemab accelerated approvalįiling for full lecanemab approval based on Clarity AD Rolling lecanemab filing for US accelerated approval Phase 2 Study 201 final 18-month analysis Ms Singhal said if Clarity-AD was positive it “could meet the bar for full CMS coverage”. The US Centers for Medicare & Medicaid Services famously slammed Aduhelm, denying broad coverage to any amyloid-beta drug that had not demonstrated a meaningful benefit on cognition and function in a controlled trial. How the FDA would consider anything else, especially after the storm whipped up by its controversial approval of Aduhelm, is another story.Īnd the same goes for reimbursement. We are considering all of this.”īiogen insists that a statistically significant effect in Clarity AD on CDR-SB would be clinically meaningful. “There could be several mixed scenarios, there could be several permutations or combinations. Ms Singhal said there was a spectrum of Clarity AD outcomes, with a positive primary hit at one end and outright failure at the other. Clarity AD enrolled 1,795 early Alzheimer’s patients, and secondary measures include changes in PET and measures on the Adas-Cog14, Adcoms and ADCS-ADL scales. This statement came in response to a question about what the company would do if Clarity AD failed on CDR-SB yet showed numerical improvement in one or more secondaries. But Priya Singhal, interim R&D head, said the group was considering a range of scenarios for the readout, due in the third quarter, adding: “The totality of the data will be very important.” With Aduhelm confirmed as a disaster, the effectively rudderless Biogen today primed investors for its next big Alzheimer’s readout, the Clarity AD trial of lecanemab, and many might be rolling their eyes at the prospect of yet another failed amyloid-beta MAb study being data dredged.Ĭlarity AD has CDR-SB as its primary endpoint, and Biogen stressed that it was gunning for a positive win here for lecanemab against placebo.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |