70 and older are living with the disease, and they are twice as likely to get dementia.
“We're very hopeful that as we get better at enrolling the right populations, as we get better at the science, we are able to actually see treatments come to the clinic and be accessible to people who may be able to benefit from them,” Carrillo said.approval is crucial for the drug to become readily available to those that need it most.
“The company has announced that it will be filing not only with the FDA, but [also] with other countries and regulatory agencies. And we hope that soon, the FDA might have an expedited review of this drug,” Carillo explained., the pharmaceutical research company stated:"Eisai aims to file for traditional approval in the U.S., and to submit marketing authorization applications in Japan and Europe by the end of Eisai FY2022, which ends on March 31, 2023.
Biotech and Eisai have an application pending for accelerated FDA approval, and a decision is expected by early January. Experts believe lecanemab will get FDA approval and Medicare coverage, unlike aducanumab, which is sold as Aduhelm, a prior Alzheimer's drug from Biogen that was approved by the FDA but received."This drug [lecanemab] has a much larger trial, much more diverse trial, and much clearer evidence of clinical benefit," Vradenburg explained.
But the side effects are concerning."Lecanemab also has a similar profile of dangerous side effects related to brain swelling and brain bleeding that we see with Aduhelm, though lecanemab is probably a bit friendlier than Aduhelm on this front, in that 'only' 10% of patients in the high-dose groups showed these side effects [in the phase 2 trial],"