Drugs / SB-497115-GR
SB-497115-GR
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed autosomal recessive severe congenital neutropenia 1 milestone | |||||
| Filed | EU (EMA) | Revolade | autosomal recessive severe congenital neutropenia | — | “Novartis submitted a Type II variation application for Revolade as a first-line SAA treatment to the European Medicines Agency in April 2018” novartis.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Approved | EU (EMA) | Eltrombopag Viatris | — | 2024-12-12 | europa.eu ↗ |
| Label expansions (5) | US (FDA) | PROMACTA | — | 2011-02-25 – 2018-11-16 | fda.gov ↗ |
| Approved | US (FDA) | PROMACTA | — | 2008-11-20 | fda.gov ↗ |
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01550185 | May 2012 → Dec 2014 | acute basophilic leukemia, acute erythroid leukemia, acute megakaryoblastic leukemia in adult, acute myeloblastic leukemia with maturation +9 | Roswell Park Cancer Institute | Terminated | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT01636778 | Jul 2012 → May 2014 | chronic hepatitis C virus infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00909363 | Jun 2009 → May 2017 | Wiskott-Aldrich syndrome, hemorrhagic disease, thrombocytopenia | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT00540423 | Sep 2007 → Dec 2008 | autoimmune thrombocytopenic purpura | GlaxoSmithKline | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2018-12-02 | Novartis Pharmaceuticals | Results Real-world data show Novartis drug Revolade® improves outcomes for ITP patients compared to other second-line therapies novartis.com ↗ |
| 2018-11-16 | Novartis Pharmaceuticals | Regulatory FDA approves Novartis drug Promacta® for first-line SAA and grants Breakthrough Therapy designation for additional new indication novartis.com ↗
Promacta receives FDA approval for first-line treatment of severe aplastic anemia (SAA) and Breakthrough Therapy designation for low platelet counts in people exposed to radiation |
| 2018-05-30 | Novartis Pharmaceuticals | Regulatory FDA expedites review of Novartis drug Promacta® for first-line severe aplastic anemia (SAA) novartis.com ↗
Promacta receives FDA Priority Review for first-line treatment of SAA based on data showing 52% complete response rate and 85% overall response rate when added to standard immunosuppressive therapy (IST) |
| 2018-01-04 | Novartis Pharmaceuticals | Regulatory Novartis drug Promacta® receives FDA Breakthrough Therapy designation for first-line use in severe aplastic anemia (SAA) novartis.com ↗ |
| 2017-10-18 | Novartis Pharmaceuticals | Results Novartis drug Revolade® shows long-term disease control for chronic/persistent immune thrombocytopenia (ITP) novartis.com ↗
Novartis today announced long-term study results supporting the positive safety and efficacy of Revolade (eltrombopag) in adults with chronic/persistent (enrolling patients that were 6 or more months from diagnosis) immune (idiopathic) thrombocytopenia (ITP) were published online in Blood. |
| 2017-04-19 | Novartis Pharmaceuticals | Results NIH study in NEJM shows Novartis drug eltrombopag as first-line therapy with standard treatment improves responses in severe aplastic anemia novartis.com ↗ |
| 2016-11-16 | Novartis Pharmaceuticals | Results Novartis data at ASH and SABCS showcase latest innovations in development for patients with blood disorders and breast cancer novartis.com ↗
Patient-Reported Health-Related Quality of Life Improves Over Time in Patients with Chronic Immune Thrombocytopenia Receiving Long-Term Treatment with Eltrombopag |
| 2016-06-10 | Novartis Pharmaceuticals | Results Novartis highlights long-term safety data of Revolade® in adults with chronic immune thrombocytopenia, a rare blood disorder novartis.com ↗
Novartis today announced data from the largest study of its kind confirming the long-term safety profile of Revolade (eltrombopag) in adults with chronic immune (idiopathic) thrombocytopenia (ITP), with data for up to 6 years in some patients (median exposure was 2.4 years). |
| 2016-04-07 | Novartis Pharmaceuticals | Regulatory Novartis receives EU approval for Revolade® as first-in-class therapy for children aged 1 year and above with chronic ITP novartis.com ↗
Novartis announced today that the European Commission (EC) has approved Revolade ® (eltrombopag) for the treatment of pediatric (aged 1 year and above) chronic immune (idiopathic) thrombocytopenic purpura (ITP) patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). |
| 2015-09-02 | Novartis Pharmaceuticals | Regulatory Novartis receives EU approval for new Revolade® use as first-in-class therapy for patients with severe aplastic anemia novartis.com ↗
Novartis announced today that the European Commission has approved Revolade ® (eltrombopag) for the treatment of adults with severe aplastic anemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for hematopoietic stem cell transplant. |
| 2015-08-24 | Novartis Pharmaceuticals | Regulatory FDA expands use of Novartis drug Promacta® to include treatment of children ages 1 and older with chronic immune thrombocytopenia novartis.com ↗ |
| 2015-07-24 | Novartis Pharmaceuticals | Regulatory Novartis drug Revolade® recommended by CHMP for EU approval to treat patients with severe aplastic anemia, a serious blood disorder novartis.com ↗ |
| 2015-06-11 | Novartis Pharmaceuticals | Regulatory Novartis gains FDA approval for Promacta® providing new option for children, ages 6 and older, with chronic ITP, a rare blood disorder novartis.com ↗
Novartis announced today that the US Food and Drug Administration (FDA) has approved Promacta ® (eltrombopag) for the treatment of children six years and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. |
| 2015-02-06 | GlaxoSmithKline | Regulatory GSK announces EU regulatory submission seeking additional indication for eltrombopag (Revolade™) gsk.com ↗
GSK today announced the submission to the European Medicines Agency (EMA) of a variation to the Marketing Authorisation for eltrombopag (Revolade™), seeking an additional indication for the treatment of paediatric patients (age 1 year and above) with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids or immunoglobulins. |
| 2014-12-22 | GlaxoSmithKline | Regulatory GSK announces US regulatory submission seeking additional indication for eltrombopag (Promacta™) gsk.com ↗ |
| 2014-11-12 | GlaxoSmithKline | Regulatory GSK announces EU regulatory submission seeking additional indication for eltrombopag (Revolade™) (1) gsk.com ↗ |
| 2014-08-26 | GlaxoSmithKline | Regulatory GSK's Promacta® (eltrombopag) receives FDA approval of an additional indication gsk.com ↗
GlaxoSmithKline plc (LSE/NYSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the once-daily use of Promacta® (eltrombopag) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST). |
| 2014-06-13 | GlaxoSmithKline | Results GSK announces results of Phase III PETIT2 study of eltrombopag (Promacta™/Revolade™) in paediatric patients with chronic immune thrombocytopenia gsk.com ↗
Issued: London UK GlaxoSmithKline (GSK) plc today announced the results from the Phase III PETIT2 study evaluating the efficacy of eltrombopag vs. placebo in paediatric patients with chronic immune (idiopathic) thrombocytopenic purpura (cITP). |
| 2014-02-28 | GlaxoSmithKline | Regulatory GSK announces submission to U.S. regulatory authorities for Promacta™ (eltrombopag) for severe aplastic anaemia gsk.com ↗ |
| 2014-02-03 | GlaxoSmithKline | Regulatory GSK gains FDA Breakthrough Therapy designation for Promacta®/Revolade® (eltrombopag) for severe aplastic anaemia gsk.com ↗
GlaxoSmithKline plc (LSE:GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Promacta®/Revolade® (eltrombopag) for the treatment of cytopenias in patients with severe aplastic anaemia (SAA) who have had insufficient response to immunosuppressive therapy. |
| 2013-09-24 | GlaxoSmithKline | Regulatory GSK receives marketing authorisation from the European Commission for additional Revolade™ gsk.com ↗ |
| 2013-07-26 | GlaxoSmithKline | Regulatory GSK receives positive CHMP opinion for REVOLADE in thrombocytopenia associated with chronic hepatitis C infection gsk.com ↗ |
| 2012-05-30 | GlaxoSmithKline | Regulatory Regulatory Update – GSK announces submissions in the EU & US for new indications for Promacta®/Revolade® gsk.com ↗
GlaxoSmithKline plc announced today that it has submitted regulatory applications in the European Union and United States related to eltrombopag |
| 2011-11-07 | GlaxoSmithKline | Results GSK presents phase III results for eltrombopag in hepatitis C virus related thrombocytopenia gsk.com ↗
The ENABLE 2 trial met its primary endpoint of improved SVR, with 19% of eltrombopag patients and 13% of placebo patients achieving SVR (p=0.0202). |
| 2010-10-28 | GlaxoSmithKline | Regulatory GlaxoSmithKline receives approval in Japan for two medicines: Revolade and Xyzal gsk.com ↗ |
| 2009-12-18 | Ligand Pharmaceuticals | Regulatory Ligand Announces Positive Regulatory Opinion in Europe for Revolade for Chronic Immune Thrombocytopenic Purpura ligand.com ↗
The CHMP has recommended the marketing authorization of eltrombopag in the European Union for the treatment of ITP in adult patients who have had their spleen removed, and who do not respond to other treatments, such as corticosteroids and immunoglobulins therapies. |
| 2009-12-17 | GlaxoSmithKline | Regulatory Revolade (eltrombopag) receives positive opinion in Europe for chronic immune thrombocytopenic purpura gsk.com ↗
The CHMP has recommended the marketing authorisation of eltrombopag in the European Union for the treatment of ITP in adult patients who have had their spleen removed, and who do not respond to other treatments, such as corticosteroids and immunoglobulins therapies. |
| 2009-06-04 | GlaxoSmithKline | Results Positive results with Revolade™ and Arzerra™ for difficult-to-treat blood disorders gsk.com ↗
New data from two long-term studies (RAISE – 197 patients and EXTEND – 144 patients) show that patients treated with eltrombopag experienced significant elevations in platelet counts, as well as a reduction in bleeding and bruising, compared with placebo. |
All press releases naming this drug 28 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SB-497115-GR | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00540423 ↗ |
| Known as | eltrombopag olamine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01550185 ↗ |
| Known as | Promacta | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00909363 ↗ |
| Action | Activate | “Eltrombopag is an oral, non-peptide thrombopoietin receptor agonist” PMID 22409309 ↗ May 2012 |
| Route | Oral | “Eltrombopag is an oral, non-peptide thrombopoietin receptor agonist” PMID 22409309 ↗ May 2012 |