After Roche initially denied conversations with the FDA about its Alzheimer’s disease drug candidate gantenerumab, CEO Severin Schwan has now confirmed they are talking to the regulator.
Schwan declined to speculate on the outcome of the talks amid reports that it will join Eli Lilly in filing for accelerated approval in Alzheimer’s.
With the accelerated approval of Biogen’s Aduhelm opening the door to the approval of Alzheimer’s drug candidates on the strength of surrogate endpoints, Lilly outlined plans to submit donanemab to the FDA last month. Shortly after, analysts at Jefferies said Roche was preparing to submit its rival therapy gantenerumab for accelerated approval.
Roche dismissed the analyst report, stating the focus remains on a phase 3 trial and discussions with the FDA would begin “when appropriate.” Now, Schwan has told reporters from publications including Reuters that Roche is talking to the FDA.
“There is a continued dialogue with the FDA. I wouldn’t be able to speculate what the outcome of this dialogue will be,” he said. “Our trial is a well-designed, very comprehensive trial so, whatever the outcome of this trial will be, we will have a definitive answer of what we can do for patients with this terrible disease so let’s keep fingers crossed.”
Schwan made the comments in conjunction with a second-quarter update that revealed the removal of assets from Roche’s early-phase pipeline. The list of programs removed from phase 1 include tests of selicrelumab combinations in solid tumors. Roche’s decision to pull the plug on trials of the CD40 drug comes two years after Johnson & Johnson walked away from an asset against the same target.
Roche also disclosed the removal of two 4D Molecular Therapeutics-partnered gene therapies from its phase 1 pipeline. 4D revealed Roche had filed to terminate its license agreement for 4D-110 in choroideremia without cause last month. Roche also had an option on X-linked retinitis pigmentosa prospect 4D-125 but has dropped the gene therapy from its pipeline less than one year after 4D took it into the clinic.
The bispecific RG6296 had a similarly short spell as a clinical-phase asset at Roche, with the Swiss pharma removing the asset from the pipeline just one year after taking it into a phase 1 clinical trial in multiple myeloma. Affimed, Roche’s partner on the project, disclosed the termination of the study “due to broader portfolio considerations” after the completion of dose escalation last month.
Finally, Roche disclosed the removal of a Chugai hyperphosphatemia prospect from its pipeline. The action comes shortly after Chugai granted Alebund Pharmaceuticals an option to pick up global rights to hyperphosphatemia candidate EOS789.