- The reintroduction of an intravenous immune globulin product to the U.S. market could help ease a supply crunch that's forced some hospitals and clinics to ration treatment with the plasma-derived therapies. The medication is used to strengthen defenses in patients with weakened immune systems.
- Last week, ADMA Biologics announced the commercial relaunch and first sales of its immune globulin Bivigam, which is approved to treat patients suffering from any one of a family of inherited immune deficiencies that increase infection risks.
- Supply of Bivigam, first approved in 2012, was curtailed by since-resolved manufacturing issues at a Boca Raton, Florida-based facility that ADMA acquired in a 2017 deal with Biotest Pharmaceuticals. In May, the Food and Drug Administration approved a supplemental application permitting ADMA to reintroduce Bivigam commercially.
Shortages of immune globulin, which consists of antibodies harvested from blood plasma, have persisted since late last year, when supply of products made by Takeda and Bio Products Lab became limited.
Since then, in April, a second Takeda drug has gone into shortage, putting pressure on hospitals and infusion clinics which treat the tens of thousands of Americans who have immune deficiency diseases.
In some cases, hospitals have resorted to suspending or canceling treatment, according to an August report from The Wall Street Journal.
The FDA recommends providers and hospitals facing supply shortages create "evidence-based" frameworks to decide who to treat. The agency is also encouraging systems with contracts for only one immune globulin product to consider adding a second. Twenty-one immune globulin products, both intravenous and subcutaneous, are currently approved, including drugs made by Takeda, Pfizer and CSL Behring.