What We’re Reading: FDA Approves First ASMD Treatment; Amended EUA for COVID-19 Boosters; Blood Type and Stroke Risk

Olipudase alfa (Xenpozyme) was granted FDA approval for patients with Acid Sphingomyelinase Deficiency (ASMD); Moderna and Pfizer-BioNTech’s bivalent COVID-19 vaccines are each authorized for use as a booster dose; people with type A blood have an 18% higher risk of stroke before age 60, compared with other blood types.

Olipudase Alfa is First FDA-approved ASMD Treatment

The FDA yesterday approved olipudase alfa (Xenpozyme) for intravenous infusion in pediatric and adult patients with the rare genetic disease Acid Sphingomyelinase Deficiency (ASMD), as announced in an FDA news release. This makes olipudase alfa the first approved medication to treat symptoms unrelated to the central nervous system in patients with ASMD. Last year, a trial found the treatment was well-tolerated and may lead to clinically meaningful improvements in patients with ASMD who do not have neurovisceral manifestations. ASMD is caused by the lack of an enzyme needed to break down sphingomyelin—a complex lipid that accumulates in the liver, spleen, lung, and brain—and causes premature death.

FDA Authorizes 2 Bivalent COVID-19 Vaccines for Use as Booster

The FDA amended the emergency use authorizations (EUAs) for the Moderna and Pfizer-BioNTech COVID-19 vaccines to authorize bivalent formulations of the vaccines for use as a single booster dose, the administration announced in a news release yesterday. Moderna’s bivalent vaccine now has EUA for use as a single booster dose in individuals aged 18 and older, and Pfizer’s bivalent vaccine has EUA for use as a single booster dose in individuals aged 12 and older. These booster doses can be administered at least 2 months after primary or booster vaccination. These bivalent vaccines contain 2 mRNA components of the SARS-CoV-2 virus, including 1 found in the original strain and 1 found in the BA.4 and BA.5 Omicron subvariants.

Blood Type Potentially Linked to Risk of Early-onset Stroke

Blood type may be linked to risk of stroke before age 60, according to a study published in Neurology. As reported by Healthline, individuals with type A blood have the highest risk of early-onset stroke before age 60 with an 18% higher risk than other blood types, while individuals with type O blood have the lowest risk, with a 12% lower chance of early-onset stroke. Additionally, people who experienced both early-onset and late stroke were more likely to have type B blood. The study authors noted there is currently no direct association established and further, more diverse research is needed.