Bioarctic’s lecanemab is approved in the US

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The brand name for lecanemab in the US will be Leqembi and the drug will include, among other things, a warning for the side effect ARIA. Important to note is that the accelerated approval is only based on phase 2 data for the antibody. Bioarctics BIOA B -5.76% Today’s development partner Eisai now intends to submit an application for full approval with data from the successful phase 3 study Clarity-AD. Once that application is submitted, the FDA has 60 days to ensure that all required data is included. After that, the FDA will set a new PDUFA date, which refers to the date the agency is expected to make a decision. If the FDA chooses to review under a priority procedure, a notification is expected within 6 months, otherwise the usual 10 months apply. Upon full approval, the US healthcare program Medicare, which insures 64 million Americans, will decide whether they intend to reimburse for the treatment or not. Medicare has previously opened up to lecanemab: “I can’t say anything specific, but the door is in any case wide open. We look at new data as soon as it arrives,” answered Medicare’s chief administrator Chiquita Brooks-LaSure to a question about how the agency will handle lecanemab, the healthcare site Stat previously wrote about. At the end of September, phase 3 results for lecanemab were presented. Compared to placebo, the antibody reduced cognitive decline by 27 percent after 18 months of treatment. During the fall and winter, there have been rumors that three patients have died due to lecanemab, causing volatile trading in the stock. Like other antibodies that attack the amyloid cascade to treat the disease, lecanemab is associated with the side effects ARIA-E (brain swelling) and ARIA-H (microbleeds in the brain). In the phase 3 study Clarity-AD, the incidence of ARIA-E was 12.5 percent in the lecanemab group and 1.7 percent in the placebo group. The incidence of ARIA-H was 17.0 percent in the lecanemab group and 8.7 percent in the placebo group. For the other approved Alzheimer’s drug, Aduhelm, the incidence of ARIA-E and ARIA-H was 35 and 19 percent, respectively. Aduhelm was approved under an accelerated procedure in the United States in the summer of 2021. This despite a lack of confirmed clinical effect and that ten of eleven members of the FDA ‘s advisory panel voted for rejection – while the last one abstained. The FDA still chose to approve the drug with the condition that the company must conduct a study that confirms the clinical effect. Sales of Aduhelm have been poor, to say the least, and last December the company halved the list price to $28,200. One reason for the weak sales is that insurance companies do not want to pay for the treatment. The influential drug pricing group ICER estimates that Bioarctic’s lecanemab will be priced between $8,500 and $20,600 for a year’s treatment. Eisai, which is responsible for setting the price, has indicated a value-based price of up to $38,000.Bioarctic is the originator of lecanemab, which has been licensed to Japanese pharmaceutical company Eisai for milestone payments and royalties. Eisai, in turn, has a collaboration with American Biogen.

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