Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.US-based biopharmaceutical firm ADMA Biologics has submitted its biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking marketing authorization for RI-002 to treat primary immunodeficiency (PI), a class of inherited genetic disorders.
Subscribe to our email newsletter
PI causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly, affecting around 250,000 people in the US.
The company noted that RI-002 showed positive results in a Phase III trial in patients with PI, meeting its primary endpoint of no serious bacterial infections (SBI).
The results, included in the submission, more than meet the requirement specified by the FDA guidance of <= 1 SBI per patient-year.
ADMA Biologics president and CEO Adam Grossman said: "This submission, combined with our recent announcement of obtaining patent protection for RI-002, places ADMA in a rare position as a company poised to transition from development to commercial stage.
"We believe that RI-002, if approved by the FDA, has great potential to provide meaningful clinical improvement for patients living with PI, as well as offers clinicians a much needed option for their immune compromised patients.
"Under PDUFA V, the BLA filing fee is $2.3m. The FDA reviewed ADMA’s small business waiver application and it was approved."
The company said that the FDA has a 60-day review period to determine whether its BLA submission for RI-002 is complete and acceptable for filing.