TRENDING TOPICS

NEW ALZHEIMER’S DISEASE DRUG APPROVED

Eisai’s lecanemab-irmb (Leqembi™), an amyloid betadirected antibody, has received Accelerated Approval for the treatment of certain patients with Alzheimer’s disease. Labeling states treatment should be started in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on starting treatment at earlier or later stages of the disease. Accelerated Approval was based on reduction in amyloid beta plaques seen in patients treated with lecanemab-irmb; therefore, continued approval for this use may require demonstration of benefit in a confirmatory clinical trial.

It is supplied as a solution in an SDV (500 mg/5 mL and 200 mg/2 mL) with recommended dosage of 10 mg/kg IV infusion over about 1 hour once every 2 weeks. The presence of amyloid beta pathology should be confirmed before starting therapy, and brain MRI should be obtained within 1 year before starting therapy to assess for preexisting amyloid related imaging abnormalities (ARIA). Additional MRIs should be performed before the 5th, 7th, and 14th infusions to assess for ARIA.

Approval was based on a phase 2, double-blind, placebocontrolled, parallel-group, dose-finding, 79-week study

The primary endpoint of change from baseline on ADCOMS (an Alzheimer’s disease composite score used in the trial) at 12 months did not meet the prespecified success criterion demonstrating a slowing of progression. However, a secondary endpoint — assessing the change from baseline to month 18 in amyloid PET SUVR in a subset of patients — showed a reduction of amyloid beta plaques in patients who received lecanemab-irmb 10 mg/kg every 2 weeks compared to placebo (p<0.0001). The most common ADRs were infusion-related reactions, headache, and ARIA-edema. Due to the Accelerated Approval , an RCT is required by the FDA to confirm clinical benefit. This phase 3 study, Clarity AD, has been completed and submitted to the FDA. Lecanemab-irmb is the second amyloid beta-directed antibody to receive Accelerated Approval; aducanumab-avwa (Aduhelm®) received FDA approval in June 2021.

BIOSIMILAR CORNER: AMJEVITA™ LAUNCH

At the end of January 2023, adalimumab-atto (Amjevita) launched on the US market. This biosimilar to adalimumab (Humira®) was FDA approved in September 2016. The launch marks the first biosimilar to adalimumab to become commercially available in the US. To date, 8 biosimilars to Humira have received FDA approval. Amjevita, a TNF blocker, is approved as a single-dose prefilled SureClick® autoinjector (40 mg/0.8 mL) and a single-dose prefilled glass syringe (20 mg/0.4 mL, 40 mg/0.8 mL). It has received FDA approval for 7 of the 9 inflammatory conditions for which Humira is approved Amjevita is not indicated for hidradenitis suppurativa or uveitis. Although approved for adults with ulcerative colitis (UC), Amjevita is not indicated for pediatric UC.

COVID-19: NOTABLE DEVELOPMENTS

Data from the CDC’s Vaccine Safety Datalink (VSD) surveillance system identified a preliminary safety concern for ischemic stroke in those ≥ 65 years old who received the Pfizer/Biontech bivalent COVID-19 vaccine. Other surveillance systems and subsequent evaluation have not replicated the safety concern. FDA’s VRBPAC convened in January 2023 to discuss future vaccine regimens for COVID-19, including the composition of primary and booster doses. The panel also discussed plans for an annual COVID-19 booster. The agency is continuing to monitor the XBB.1.5 subvariant of Omicron as it continues to increase across the US. The EUA for tixagevimab co-packaged with cilgavimab (Evusheld™) has been revised to limit its use for preexposure prophylaxis of COVID-19 when the majority of circulating variants are not expected to be susceptible to the agent; as a result, Evusheld is no longer authorized for use. The CDC has published an MMWR on safety monitoring of bivalent COVID-19 mRNA vaccine booster doses in children 5 to 11 years old; preliminary data demonstrates similar safety with the bivalent booster as observed with the monovalent booster. The ICER has published an updated assessment on value-based pricing of ritonavir-boosted nirmatrelvir (Paxlovid™) as an outpatient treatment for COVID-19, providing an update of the initial May 2022 analysis. Please refer to the COVID-19 disclaimer at the end of the publication.