MorningRX: August 18, 2023


NIH establishes research centers for maternal health, FDA grants priority review for IgA nephropathy treatment, and the CDC begins tracking a new COVID-19 variant.

NIH Creates Research Center Focused on Maternal Health

The National Institutes of Health has awarded first-year funding to 10 research centers to focus on improving maternal health, according to a press release. The $24 million granted by the health agency will establish the Maternal Health Research Centers of Excellence, part of NIH’s Implementing a Maternal Health and Pregnancy Outcomes Vision for Everyone initiative. The research centers will focus on developing and evaluating innovative approaches to reduce pregnancy-related complications and deaths, as well as promote maternal health equity.

“The magnitude and persistence of maternal health disparities in the United States underscore the need for research to identify evidence-based solutions to promote health equity and improve outcomes nationwide,” Diana W. Bianchi, MD, director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said in a release. “Through collaborations with community partners and others, the Maternal Health Research Centers of Excellence will generate critical scientific evidence to help guide clinical care and reduce health disparities during and after pregnancy.”

IgA Nephropathy Treatment Gets Priority Review for Full Approval by FDA

Calliditas Therapeutics announced that its IgA nephropathy treatment budesonide (TARPEYO) has been granted priority review for full approval by the FDA, the company announced in a press release on Friday. The therapy is currently approved under accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression. The decision will be based on data from a Phase 3 trial which demonstrated a statistically significant benefit over placebo in estimated glomerular filtration rate over two years.

“We take great pride in the strong clinical evidence we have gathered, which we believe demonstrates TARPEYO’s durable and clinically meaningful impact on kidney function in the treatment of IgAN,” Richard Phillipson, Chief Medical Officer at Calliditas, said in a release. “The combination of the significant eGFR benefit and the reduction in proteinuria lasting for the entire 15-month follow-up period in the full results of our Phase 3 study provide strong rationale for establishing TARPEYO as the standard of care for IgAN patients.”

CDC Tracking New COVID-19 Variant

A new highly mutated COVID-19 variant called BA.2.86 is being tracked by the CDC, according to Reuters.The variant, which has so far been detected in the United States, Denmark, and Israel, has 36 mutations from the XBB.1.5 variant. Reuters reported that early analysis indicates the BA.2.86 variant will either have equal or greater escape than XBB.1.5 from antibodies created by previous variants.

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