According to a press release from New Jersey-headquartered ADMA Biologics, the FDA has approved the company’s primary humoral immunodeficiency disease (PIDD) drug Asceniv for the American market. The company expects to roll out the product sometime in the latter half of the year.
About Primary Humoral Immunodeficiency Syndrome
PIDD and other immunodeficiency syndromes are typically genetically inherited conditions characterized by a weakened immune system. This is due to a deficiency of pathogen-destroying immunoglobulins – also known as antibodies – which are produced mainly by plasma cells in the blood.
Due to their weakened immune systems, PIDD patients suffer from frequent, chronic infections. They’re also much more likely to suffer from complications stemming from these infections.
Typically, PIDD and similar conditions are treated with a monthly immune globulin replacement therapy. Without this “antibody transplant,” PIDD patients are vulnerable to serious infection.
About Asceniv
The FDA’s approval comes at the tail end of Asceniv’s successful phase 3 clinical trial. A study of 59 individuals with PIDD involved regularly infusing patients with the plasma-derived drug for an entire year. Respondents were evaluated in accordance to their rates of serious bacterial infections. Researchers also questioned patients about other health benchmarks, such as days taken off school or work, days spent on antibiotics, or days spent hospitalized from infection.
Over the course of the year, zero serious bacterial infections reported among the 59 individuals. That’s an impressive achievement by anyone’s standards.
Since nearly 250,000 Americans are living with PIDD, a better kind of treatment than regular plasma exchange was badly needed for some time. Asceniv does come with some potential side effects, including possible kidney failure – but this is a side effect of other intravenous immune globulin (IVIG) treatments as well. In all likelihood, thousands of Americans – and potentially thousands more across the world – stand to benefit when Asceniv hits the market.
“…We believe there is an opportunity to treat meaningful segments of this patient population,” ADMA Biologics President and CEO Adam Grossman said of the approval. Grossman also hopes that his drug will help alleviate some of what he believes to be a shortage in the United States’ IVIG supply.
PIDD affects about a quarter of a million Americans. Even if just 1% is eligible for Asceniv, that’s thousands of potentially improved lives. What do you think of this exciting news? Share your thoughts with Patient Worthy!
