Drugs / RI-002
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed immunodeficiency 112 1 milestone | |||||
| Filed | US (FDA) | — | immunodeficiency 112 | 2015-07-31 | “announced that it has submitted its Biologics License Application (BLA) to the United States Food and Drug Administration (FDA), seeking marketing authorization for RI-002.” admabiologics.com ↗ |
| Filed immunodeficiency-associated lymphoproliferative disease 1 milestone | |||||
| Filed | US (FDA) | — | immunodeficiency-associated lymphoproliferative disease | 2015-09-18 | “a Biologics License Application (BLA) for RI-002 was accepted by the U.S. Food and Drug Administration (FDA) on September 18, 2015.” admabiologics.com ↗ |
| Filed inborn error of immunity 1 milestone | |||||
| Filed | US (FDA) | — | inborn error of immunity | 2018-09-28 | “resubmitted its Biologics License Application (“BLA”) for RI-002 its product candidate to the U.S. Food and Drug Administration (“FDA”) on September 28, 2018.” admabiologics.com ↗ “RI-002’s Biologics License Application (“BLA”) resubmission” admabiologics.com ↗ |
| Rejected Indication not stated 1 milestone | |||||
| Rejected (CRL) | US (FDA) | — | primary humoral immunodeficiency disease | 2016-07-29 | “FDA has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for RI-002” admabiologics.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT01814800 | Feb → Dec 2014 | inborn error of immunity | ADMA Biologics, Inc. | Completed | Met primary |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2019-10-07 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Data Presented at IDWeek 2019 admabiologics.com ↗
The poster detailed data obtained from the compassionate use of ASCENIV™ (formerly referred to as RI-002) in the treatment of Respiratory Syncytial Virus (“RSV”) infection in two immunocompromised children. |
| 2019-04-01 | ADMA Biologics, Inc. | Regulatory FDA Approves ASCENIV™, a Novel Intravenous Immune Globulin admabiologics.com ↗ |
| 2018-10-17 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Receives PDUFA Date for RI-002 admabiologics.com ↗
The FDA stated that it considers the RI-002 BLA resubmission ‘a complete, Class 2 response’ and has established an action due date of April 2, 2019, under the Prescription Drug User Fee Act (“PDUFA”). |
| 2018-10-01 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Resubmits Biologics License Application for RI-002 admabiologics.com ↗
The Company was able to resubmit RI-002’s BLA as a direct result of the recent improvement in compliance status for the Company’s Boca Raton, FL manufacturing facility to Voluntary Action Indicated (“VAI”), as previously announced in September 2018. |
| 2016-07-29 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Receives Complete Response Letter from FDA for Pending Biologics License Application admabiologics.com ↗ |
| 2016-04-12 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Data on RI-002 to be Presented at the Clinical Immunology Society 2016 Annual Meeting admabiologics.com ↗
In addition, the data presented will also demonstrate that RI-002 prevents infection in cotton rats challenged with influenza and suppresses inflammatory cytokines induced by influenza. |
| 2016-03-07 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Data Presented at 2016 American Academy of Allergy Asthma & Immunology Annual Meeting (AAAAI) admabiologics.com ↗
The data demonstrate that while palivizumab and RI-002 were comparable in diminishing the viral load in the lungs of RSV infected cotton rats, only RI-002 was effective in preventing RSV infection when a palivizumab-resistant strain of RSV was administered. |
| 2015-11-03 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Data to be Presented at the International Primary Immunodeficiencies Congress in Budapest Hungary admabiologics.com ↗
The data also demonstrates the presence of higher anti- RSV neutralizing activity in RI-002 as compared to that which is present in palivizumab in this animal model. |
| 2015-09-30 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Receives Milestone Payment From Biotest AG for RI-002 BLA Submission to FDA admabiologics.com ↗
announced it has received a milestone payment from Biotest Aktiengesellschaft (Biotest AG) as a result of the filing of its Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) |
| 2015-09-21 | ADMA Biologics, Inc. | Regulatory FDA Accepts ADMA Biologics License Application for RI-002 admabiologics.com ↗ |
| 2015-07-31 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Announces Submission of RI-002 Biologics License Application (BLA) to FDA admabiologics.com ↗
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the primary immunodeficiency (PI) population and the treatment and prevention of certain infectious diseases, announced that it has submitted its Biologics License Application (BLA) to the United States Food and Drug Administration (FDA), seeking marketing authorization for RI-002. |
| 2015-06-30 | ADMA Biologics, Inc. | Regulatory ADMA Biologics Receives Notice of Allowance for U.S. Patent Pertaining to Its Lead Product Candidate RI-002 admabiologics.com ↗
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company, announced that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. patent application 14/592,721 entitled Compositions and Methods For The Treatment of Immunodeficiency. |
| 2015-02-23 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Positive Data on Primary and Secondary Endpoints from its Pivotal Phase III Clinical Trial for RI-002 at the AAAAI Medical Conference admabiologics.com ↗
ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced positive results on the primary and secondary endpoint evaluations from its pivotal Phase III trial for RI-002 in Primary Immune Deficiency Disease (PIDD) in a poster presentation yesterday at the American Academy of Allergy, Asthma and Immunology Annual Meeting (http://annualmeeting.aaaai.org). |
| 2014-12-15 | ADMA Biologics, Inc. | Results ADMA Biologics Receives $5M Tranche From Hercules Technology Growth Capital admabiologics.com ↗
The $5 million was based upon ADMA achieving clinical endpoints of a Phase III clinical study of RI-002 as a treatment for Primary Immunodeficiency Disease (PIDD), under its existing loan and security agreement. |
| 2014-12-03 | ADMA Biologics, Inc. | Results ADMA Biologics Announces Positive Top-Line Phase III Data for Primary Immune Deficiency Disease (PIDD) Patients admabiologics.com ↗
While final data from the study will be reported during the first quarter of 2015, preliminary analysis indicates that treatment with RI-002 resulted in no serious bacterial infections (SBI) observed in study subjects during the trial. |
| 2014-11-10 | ADMA Biologics, Inc. | Results ADMA Biologics to Present at the 9th International Respiratory Syncytial Virus (RSV) Symposium admabiologics.com ↗ |
| 2013-10-29 | ADMA Biologics, Inc. | Results RSV Vaccines for the World 2013 Conference Presentation Highlights Data from ADMA Biologics’ Human and Animal Study Experience admabiologics.com ↗
The data presented at the 2013 RSVVW demonstrates the potential for offering a polyclonal immune globulin product with standardized, elevated levels of anti-RSV antibodies in immune-compromised patient populations, |
All press releases naming this drug 20 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RI-002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01814800 ↗ |
| Route | Intravenous | “RI-002 administered as an intravenous infusion” NCT01814800 ↗ |