May was host to a duo of updates from the US Food and Drug Administration (FDA) on the hematological pipeline, updates from the 61st European Renal Association (ERA) Congress on the link between anemia and nephrology conditions, and innovations driving the field forward with artificial intelligence and handheld detection of the common blood disorder.

Here are the top 7 stories in hematology from May 2024.

FDA News

FDA Updates ALTUVIIIO Label with Full Pediatric Data in Hemophilia A

On May 10, 2024, the FDA approved an update to the label for Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein-ehtl (ALTUVIIIO®) for pediatric hemophilia A, based on full data from the phase 3 XTEND-Kids study.

Granted FDA approval in February 2023, this label update builds on interim data included in the initial label. These data showed that once-weekly ALTUVIIIO dosing achieved highly-effective bleed protection for children with hemophilia A.

“Hemophilia is a lifelong condition, so starting children on an early prophylactic regimen can help them stay ahead of bleeds and reduce other potential complications, such as joint damage and pain,” said Mindy Simpson, MD, a pediatric hematologist/oncologist and assistant professor of pediatrics at Rush University Medical Center.

FDA Clears IND Application for CID-103 in Immune Thrombocytopenia

The FDA cleared the investigational new drug (IND) application for CID-103 for treating adults with chronic immune thrombocytopenia (ITP).

Announced on May 15, 2024, the IND application was initially submitted in April to support a Phase 1/2 study of CID-103 in adults with ITP. On May 13, CASI Pharmaceuticals received an FDA letter supporting the advancement of the study.

“We are excited to advance this program into clinical development as CID-103 has the potential to represent a new therapeutic option to help alleviate the disease burden in this patient community,” said Wei-Wu He, PhD, chief executive officer of CASI Pharmaceuticals.

European Renal Association (ERA) Congress

SGLT2 Inhibitors Can Improve Anemia in Patients with CKD

A new study presented at the 61st ERA Congress builds on previous research into the effect of SGLT2 inhibitors on hemoglobin levels for individuals with CKD. In the prospective study evaluating dapagliflozin (Farxiga) in anemia and CKD, the use of SGLT2 inhibitors was found to reduce anemia risk, even without using iron supplementation or erythropoietin therapy.

“The use of dapagliflozin for 8 months resulted in a significant elevation in hemoglobin levels in patients with CKD,” wrote investigators.

Anemia Increases Risk of End-Stage Kidney Disease in IgA Nephropathy

Another analysis at ERA 2024 revealed the presence of anemia at biopsy elevated the risk of end-stage kidney disease (ESKD) in patients with IgA nephropathy.

Across more than 800 patients receiving care over approximately 20 years, a reduced hemoglobin level was present in nearly 20% of patients with IgA nephropathy. Further analysis showed the presence of reduced hemoglobin was associated with an increased likelihood of reduced serum albumin, estimated glomerular filtration rate (eGFR), and progression to ESKD.

“Therefore, it is necessary to monitor Hb levels at the time of diagnosis and take proactive measures to reduce the risk of disease progression,” wrote investigators.

Anemia Diagnostic Tests Infrequent, Linked to Low Treatment Rates in CKD

In a single-center, observational, retrospective study, diagnostic tests for anemia were inadequately ordered, resulting in a significant majority of anemic patients with advanced CKD without adequate treatment.

Data from the Hacettepe University Faculty of Medicine Nephrology Clinic revealed more than half (59.4%) of patients with anemia did not receive any form of treatment, including those whose ferritin level was checked, and their levels were <100 µg/dL.

“We recommend an optimal evaluation of CKD patients with anemia and initiating treatment as early as possible,” added investigators.

Imaging Modalities

Smartphone App Accurate in Anemia Detection from Conjunctival Images

A smartphone application was accurate in the non-invasive, real-time detection and classification of anemia, based on conjunctival images. The app utilizes a novel 32-bit imaging process method to predict anemia using digital images on the conjunctiva, with real-time local processing.

“Given the high prevalence of anemia and its associated morbidity and mortality, the development of an accurate and accessible anemia screening tool is essential to reduce the risk of health complications and alleviate the social and economic burdens associated with untreated anemia,” wrote investigators.

Artificial Intelligence Algorithms Detect Anemia from Fundus Images

Artificial intelligence-based detection of anemia from retinal fundus images could benefit patients receiving routine retinal imaging. A classification algorithm, trained and developed across three network architectures, showed high sensitivity and specificity in detecting anemia from the fundus images, despite slight differences between the three networks.

“The convolutional neural networks tested in this study hold promise for early and non-invasive diagnosis of anemia, thereby reducing associated health risks,” wrote investigators.