PI Drug RI-002 BLA accepted by FDA

Source: ADMA Biologics

In July, Patient Worthy published BREAKING news about ADMA Biologics, Inc.’s promising new drug; RI-002, a specialty IGIV treatment for patients who are immune-compromised.

RI-002 data proved the drug’s ability to prevent infections, and the associated Phase III trial proved successful without any serious bacterial infections (SBI) reported. The Biologics License Application (BLA) for RI-002 was submitted to the FDA on July 31st in pursuit of an indication to treat primary immune deficiency disease, or PIDD.

Yesterday, the company released a press statement about the FDA’s acceptance of the BLA for RI-002.  ADMA Biologics Inc. received U.S. Patent 9,107,906 for RI-002 under the title- Compositions And Methods For The Treatment of Immunodeficiency.

Vaccine News Daily quoted ADMA Biologics’ President and CEO, Adam Grossman saying,

“The company will continue to aggressively pursue additional proprietary rights encompassing this technology.”
The FDA estimates RI-002’s complete the review later in 2016. For more information, please visit the company’s website at www.admabiologics.com.   Download the .pdf press release here.

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